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This page describes products and general use; it is not medical advice.
Short answer: FDA’s own pages describe pulse oximeters for medical purposes as cleared, not approved, and say oximeters sold as general wellness or sporting/aviation products are not reviewed by the agency before they reach the public. This guide is for clinic staff, buyers and students who need to read an “FDA approved pulse oximeter” claim correctly. Facts below were checked against FDA sources on 2026-10-30.
Are pulse oximeters FDA approved or FDA cleared?
FDA’s consumer page Pulse Oximeter Basics uses the word “clearance”. It says a small number of pulse oximeters intended for medical purposes are available over the counter “following clearance by the FDA”. In the openFDA classification data, the oximeter product codes DQA, OLK and OCH are Class II under 21 CFR 870.2700, which defines an oximeter as “a device used to transmit radiation at a known wavelength(s) through blood”. So “FDA cleared pulse oximeter” (also written “FDA-cleared”) matches the regulator’s own vocabulary; “FDA approved pulse oximeter” is the phrase most sellers and searchers use for the same idea.
Who uses it: per FDA, medical-purpose oximeters are primarily used in hospital settings or doctors’ offices, while wellness and sporting oximeters are sold directly to consumers in stores or online.
Medical, over-the-counter and wellness oximeters
FDA describes three groups. Medical-purpose devices are used to monitor (trend or spot check) oxygen saturation to help in clinical decision-making. A small number of those are sold over the counter after clearance. General wellness and sporting/aviation oximeters “are not reviewed or evaluated by the agency before being available to the public” and are “not evaluated by the agency for use in clinical decision-making or determining whether to seek medical intervention”.
| openFDA product code | Name in openFDA | Intended use as worded by openFDA |
|---|---|---|
| DQA | Oximeter (Class 2, 21 CFR 870.2700) | No definition text in the record |
| OLK | Pulse Oximeter For Over-The-Counter Use (Class 2, 21 CFR 870.2700) | “Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring” |
| OCH | Oximeter, Infrared, Sporting, Aviation (Class 2, 21 CFR 870.2700) | “Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.” |
| PGJ | Oximeter, Wellness (Class 2, 21 CFR 870.2700) | “Pulse oximeter intended for wellness use.” |
Source: openFDA device classification endpoint, queried 2026-10-30.
How to look up a device’s clearance record
The openFDA 510(k) endpoint returns clearance records by product code. On 2026-10-30 the query for OLK returned two records: K214115 (MightySat -OTC, Masimo Corporation, decision 2024-01-31, “Substantially Equivalent”) and K211498 (Nonin OTC Pulse Oximeter Model 3250, Nonin Medical, decision 2024-11-13, “Substantially Equivalent”). These are database records on the query date, not a complete list of oximeters on the market and not an endorsement. A clearance claim for a specific device should correspond to a K number in a record like these.
Fingertip and wearable oximeters
The only over-the-counter oximeter product code in the data above, OLK, is defined as a non-wearable, fingertip device for non-continuous monitoring. FDA describes a pulse oximeter as a device usually clipped on a fingertip that uses light beams to estimate oxygen saturation (SpO2) and pulse rate.
What the 2025 draft guidance changes
In January 2025 FDA published the draft guidance Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (docket FDA-2023-N-4976). It is marked “not for implementation” and contains non-binding recommendations. Its stated basis includes that accuracy can be affected by, among other factors, a person’s skin pigmentation. It covers pulse oximeters for medical purposes; it does not make wellness devices cleared ones.
How to choose between categories
Only criteria stated in FDA’s pages are used here: decide whether the intended use is medical (clinical decision-making) or wellness, because FDA evaluates only the former before sale; and follow the manufacturer’s instructions for use.
Safe use and handling basics
Follow the manufacturer’s instructions for use. FDA lists poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use and fingernail polish as factors that can affect the accuracy of a reading. Readings should be considered with other information, and only a health care provider can diagnose a medical condition.
Common mistakes
- Treating “FDA approved” in marketing as proof of clearance. A K number in a 510(k) record is the checkable item.
- Assuming a wellness or sporting oximeter was evaluated for clinical decision-making. FDA says it was not.
- Reading the January 2025 draft guidance as a binding requirement.
FAQ
What is an FDA cleared pulse oximeter?
A pulse oximeter intended for medical purposes that has received FDA clearance; the clearance record carries a K number.
Is there an FDA approved fingertip pulse oximeter?
FDA’s over-the-counter product code OLK is a non-wearable fingertip category, and openFDA showed two clearance records under it on 2026-10-30. Fingertip oximeters sold as wellness products are not reviewed by FDA before sale.
Is there an FDA approved wearable pulse oximeter?
The over-the-counter pulse oximeter code is defined as non-wearable. No cleared wearable oximeter is named here, because FDA’s sources cited on this page do not list one. A wearable sold as a wellness product is not reviewed by FDA before sale.
Is there an FDA approved pulse oximeter list?
The records above are retrievable by product code from openFDA; this page does not claim a complete list.
What is FDA’s pulse oximeter guidance?
The main item is the January 2025 draft guidance described above, alongside FDA’s consumer update on oximeter basics.
Related guides and products
See what a pulse oximeter is, choosing diagnostic and patient monitoring equipment, capnography and blood gas analyzers. Product categories are listed under diagnostic, monitoring and imaging.
Sources
All sources checked on 2026-10-30.
- FDA, Pulse Oximeter Basics (content current as of 03/26/2025).
- FDA, draft guidance, Pulse Oximeters for Medical Purposes, January 2025.
- openFDA, device classification endpoint and 510(k) endpoint.
- 21 CFR 870.2700, Oximeter (Cornell Legal Information Institute).
