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Shenzhen Witleaf Medical Electronics Co., Ltd.

WIT-S300C (v1.12)

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.81%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

250

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

EDAN INSTRUMENTS, INC.

H100b Pulse Oximeter (2020)

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 3.18%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

268

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

ACARE TECHNOLOGY CO., LTD.

(2023) Model AH-TA

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.40%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

250

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE

MASIMO CORPORATION

Masimo Rad-97 Pulse Co-Oximeter with the Adult Reusable Sensor

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 3.48%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

1730

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

Zug Medical Systems SAS

SPLF-SE

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.0%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

1125

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

UTECH

UT100

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.72%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

190

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

Shenzhen Med-link Electronics Tech Company, Limited

AM801

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OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.2%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

30

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

SHENZHEN CREATIVE INDUSTRY CO., LTD

Pc-60NW Fingertip Oximeter

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 1.61%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

40

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD

Fingertip Pulse Oximeter FPD-500A

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 5.4%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

20

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2016)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

Shenzhen Aeon Technology Co., Ltd.

(A310L) Pulse Oximeter

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.9%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

10

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

Santamedical

SM-110OS

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.0%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

20

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

Samsung

Galaxy S9

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.6%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

500

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2021)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

NONIN MEDICAL, INC.

Pulse Oximeter Onyx 9590

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.24%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

200

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

NONIN MEDICAL, INC.

Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.20%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

500

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

NONIN MEDICAL, INC.

CO-Pilot Wireless Handheld Multi-Parameter System (H500) with 8330AA Adult Reusable Sensor

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 1.4%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

5999.00

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

FDA 510K

MASIMO CORPORATION

Masimo Rad-G Pulse Oximeter with Rad-G™ Reusable Finger Clip Sensor

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 3.13%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

485

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

MASIMO CORPORATION

Masimo Rad-G Pulse Oximeter with Adult Reusable Sensor

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 4.70%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

485

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

MASIMO CORPORATION

(2024) Masimo Mightysat Rx Fingertip Pulse Oximeter

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.42%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

299

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

No data

Preliminary Verified (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

MASIMO CORPORATION

(2020) Masimo Mightysat Rx Fingertip Pulse Oximeter

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 3.43%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

299

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

Innovo Medical

iP900AP // M430N-OFWH

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.0%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

35

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2020)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

Hunan Accurate Bio-Medical Technology Co., Ltd.

FS20E

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

No data

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

20

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

Hunan Accurate Bio-Medical Technology Co., Ltd.

FS10D

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 4.3%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

20

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2021)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE

GUANGDONG BIOLIGHT MEDITECH CO., LTD.

Fingertip Pulse Oximeter, Model M70, And Handheld Pulse Oximeter, Model M700

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 5.08%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

60

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Preliminary Failed (2024)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K

FaceLake

BD13075 //FL400

Read more

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 3.3%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

18

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

Unverified (2021)

The Open Oximetry Project is evaluating the performance of many popular pulse oximeters.

- VERIFIED: The device performs in accordance with (2024-2025) updated FDA and ISO regulatory frameworks. ***These regulations have not yet been released and thus no devices are considered 'verified' at this time.

- PRELIMINARY VERIFIED: The device performs in accordance with 2013 FDA premarket notification submissions guidance and ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- PRELIMINARY FAILED: The device does NOT perform in accordance with 2013 FDA premarket notification submissions guidance or ISO 80601-2-61 (2017) when tested using the Open Oximetry laboratory-based testing protocol.

- UNVERIFIED, TESTING UNDERWAY: The device is currently being tested by Open Oximetry

- UNVERIFIED: The device is not being tested by Open Oximetry at this time

CE
FDA 510K
Product Model
WIT-S300C (v1.12) chevron-right-blue
Shenzhen Witleaf Medical Electronics Co., Ltd.

Preliminary Verified (2024)

Arms 2.81%
No data
No data
No data
No data
H100b Pulse Oximeter (2020) chevron-right-blue
EDAN INSTRUMENTS, INC.

Preliminary Failed (2024)

Arms 3.18%
No data
No data
No data
No data
(2023) Model AH-TA chevron-right-blue
ACARE TECHNOLOGY CO., LTD.

Preliminary Verified (2024)

Arms 2.40%
Arms 1.1-2%
No data
No data
No data
Masimo Rad-97 Pulse Co-Oximeter with the Adult Reusable Sensor chevron-right-blue
MASIMO CORPORATION

Preliminary Failed (2024)

Arms 3.48%
Arms 1.1-2%
No data
No data
No data
No data
SPLF-SE chevron-right-blue
Zug Medical Systems SAS

Preliminary Verified (2024)

Arms 2.0%
No data
No data
No data
No data
No data
UT100 chevron-right-blue
UTECH

Preliminary Verified (2024)

Arms 2.72%
No data
No data
No data
No data
No data
AM801 chevron-right-blue
Shenzhen Med-link Electronics Tech Company, Limited

Preliminary Verified (2024)

Arms 2.2%
No data
No data
No data
No data
Pc-60NW Fingertip Oximeter chevron-right-blue
SHENZHEN CREATIVE INDUSTRY CO., LTD

Preliminary Verified (2024)

Arms 1.61%
No data
No data
No data
No data
Fingertip Pulse Oximeter FPD-500A chevron-right-blue
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD

Unverified (2016)

Arms 5.4%
Arms 1.1-2%
No data
No data
No data
(A310L) Pulse Oximeter chevron-right-blue
Shenzhen Aeon Technology Co., Ltd.

Preliminary Verified (2024)

Arms 2.9%
No data
No data
No data
No data
SM-110OS chevron-right-blue
Santamedical

Unverified (2024)

Arms 2.0%
Arms 1.1-2%
No data
No data
No data
Galaxy S9 chevron-right-blue
Samsung

Unverified (2021)

Arms 2.6%
No data
No data
No data
No data
Pulse Oximeter Onyx 9590 chevron-right-blue
NONIN MEDICAL, INC.

Preliminary Verified (2024)

Arms 2.24%
Arms 1.1-2%
No data
No data
No data
Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 chevron-right-blue
NONIN MEDICAL, INC.

Preliminary Verified (2024)

Arms 2.20%
No data
No data
No data
No data
CO-Pilot Wireless Handheld Multi-Parameter System (H500) with 8330AA Adult Reusable Sensor chevron-right-blue
NONIN MEDICAL, INC.

Preliminary Verified (2024)

Arms 1.4%
No data
No data
No data
No data
No data
Masimo Rad-G Pulse Oximeter with Rad-G™ Reusable Finger Clip Sensor chevron-right-blue
MASIMO CORPORATION

Preliminary Failed (2024)

Arms 3.13%
Arms 1.1-2%
No data
No data
No data
No data
Masimo Rad-G Pulse Oximeter with Adult Reusable Sensor chevron-right-blue
MASIMO CORPORATION

Preliminary Failed (2024)

Arms 4.70%
Arms 1.1-2%
No data
No data
No data
(2024) Masimo Mightysat Rx Fingertip Pulse Oximeter chevron-right-blue
MASIMO CORPORATION

Preliminary Verified (2024)

Arms 2.42%
No data
No data
No data
No data
No data
(2020) Masimo Mightysat Rx Fingertip Pulse Oximeter chevron-right-blue
MASIMO CORPORATION

Preliminary Failed (2024)

Arms 3.43%
Arms 1.1-2%
No data
No data
No data
iP900AP // M430N-OFWH chevron-right-blue
Innovo Medical

Unverified (2020)

Arms 2.0%
No data
No data
No data
No data
FS20E chevron-right-blue
Hunan Accurate Bio-Medical Technology Co., Ltd.

Unverified

No data
Arms 1.1-2%
No data
No data
No data
FS10D chevron-right-blue
Hunan Accurate Bio-Medical Technology Co., Ltd.

Unverified (2021)

Arms 4.3%
Arms 2.1-3%
No data
No data
No data
Fingertip Pulse Oximeter, Model M70, And Handheld Pulse Oximeter, Model M700 chevron-right-blue
GUANGDONG BIOLIGHT MEDITECH CO., LTD.

Preliminary Failed (2024)

Arms 5.08%
Arms 1.1-2%
No data
No data
No data
BD13075 //FL400 chevron-right-blue
FaceLake

Unverified (2021)

Arms 3.3%
No data
No data
No data
No data
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