FS10D

Some oximeters may be rebranded, relabeled and sold by multiple distributors under different names. We are attempting to compile 'aliases' for devices.

We categorize devices as fingertip, handheld, benchtop, multimodal, phone-based or wearable.

Some devices may have capability to function as transmission and reflectance modes using different probe types. Read more about the difference between reflectance and transmittance devices in our FAQ.

This indicates the intended patient populations for the device (adult, pediatrics, neonates), as specified by our review of the manufacturers' published specifications. Use in certain patient populations may require procurement of a separate probe.

This indicates the location where the device is manufactured as stated by the manufacturer (or the stated location of the manufacturer). Please note, devices may contain components manufactured in different location.

"Ingress Protection" ratings define levels of sealing effectiveness of devices from foreign bodies (e.g. dust) and moisture. Read more at our FAQ.

Here we report retail purchase costs (US $) 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.

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 below to see the formula and adjust this assumptions to your local data.

Here we try to report device features such as signal quality indicator, waveform, carboxy-Hb, perfusion index and ability to measure Hb.

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. 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 how details on how many subjects have been tested as well as details of skin color testing.

This is the date that the Open Oximetry collected data in the UCSF Hypoxia Lab data to 'verify' or 'dispute' device performance. If Arms data were obtained from a source other than the Hypoxia Lab, please review the date for that source. Of note, device performance may be specific to a model year (even if the model name has not changed).

Root mean square error (Arms) is a common measure of pulse oximeter device performance. 'Arms' may be ascertained from manufacturers' published data, 510k reports, package inserts or primary data from testing conducted by the UCSF Hypoxia Lab. Devices independently tested by the Open Oximetry Project will be marked 'verified' or 'disputed' depending on study findings.

Open Oximetry attempts to request CE certificates from manufacturers and distributors though this is not always possible. Read more about CE marking in our FAQ..

Here are select manuscripts published in the peer-reviewed literature.

We are working to gather device performance data published directly by manufacturers.

We are working to gather data on device performance during varying conditions such as low perfusion. We are also working to standardize protocols for such testing. Read more on 'perfusion' in our FAQ.

We are working to gather raw data for device performance to share for independent analysis. We expect to launch this feature later in 2023.

We are working on novel in vitro testing protocols for both commercially available devices (e.g. Fluke ProSim8) and novel in vitro devices. We expect to report data for this testing later in 2023.

Here we link to studies conducted in the clinical settings