A pulse oximeter (or pulse ox) is a device that is usually placed on a fingertip and uses light beams to estimate the oxygen saturation of the blood and the pulse rate. Oxygen saturation gives information about the amount of oxygen carried in the blood. A pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

On this page:

• Use of Pulse Oximeters
• Discussion Paper and Request for Feedback on Pulse Oximeters
• Public Advisory Committee Meetings on Pulse Oximeters
• Safety Communication on Pulse Oximeters

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Use of Pulse Oximeters

If you are using a pulse oximeter to monitor your oxygen levels at home and are concerned about the reading, contact a health care provider. Do not rely only on a pulse oximeter. It also is important to keep track of your symptoms or how you feel. Contact a health care provider if your symptoms are serious or get worse.

To get the best reading when using a pulse oximeter at home and to become familiar with other signs of low oxygen levels, see Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy: FDA Consumer Update.

Discussion Paper and Request for Feedback on Pulse Oximeters

On November 16, 2023, the FDA published a discussion paper, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity. The discussion paper is intended to offer an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters, taking into consideration patient skin pigmentation and patient-reported race and ethnicity. 

The FDA invites public and stakeholder feedback on a series of questions related to the approach. The comment period is open until January 16, 2024.

Submit comments by January 16, 2024

Public Advisory Committee Meetings on Pulse Oximeters

Additionally, the FDA will hold a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on February 2, 2024, from 9 a.m. to 6:30 p.m. Eastern Time. The committee will discuss pulse oximeters, including:

• an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation, and patient-reported race and ethnicity, 
• the type and amount of data that should be provided by manufacturers for the FDA to evaluate the performance of pulse oximeters submitted for premarket review, including prescription and over-the-counter indications, and labeling considerations, and
• ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation.

For additional meeting details, see the meeting announcement in the Federal Register.

Previously, on November 1, 2022, the FDA convened a virtual public meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to share information and perspectives from interested parties about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.

Safety Communication on Pulse Oximeters 

The FDA issued a safety communication in 2021 informing patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered. Multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish. 

The FDA will keep the public informed if significant new information becomes available.

Resources

• Report a Problem with a Medical Device
• CDRH Statement
• February 2, 2024: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
• November 1, 2022: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting