Is my pulse oximeter accurate?

The Best Fingertip Pulse Oximeters, Only the FDA Cleared Ones

Most pulse oximeters on Amazon are sold "for sport and aviation use only" and were never reviewed by the FDA. These fingertip oximeters are named in an FDA 510(k) clearance, with the link so you can check it yourself.

8 min read Validated picks only 6 sources

Search Amazon for a pulse oximeter and you will find hundreds of them, most with a bright screen, a lanyard and plenty of stars. Scroll down to the small print and a lot of them say the same thing: “for sports and aviation use only” or “not intended for medical use”. That line matters more than anything else on the page.

The FDA sorts pulse oximeters into two groups. Some are intended for medical purposes, and those go through FDA review before they are sold. Others are sold as general wellness or sporting and aviation products, and the FDA says plainly that these “are not reviewed or evaluated by the agency before being available to the public.” Every oximeter below is in the first group: its exact model is named in an FDA 510(k) clearance, and every card links to that clearance so you can read it yourself. Then, and only then, it also had to be well rated by buyers on Amazon.

The short version

  1. Best overall

    BLT (Biolight) M70B Fingertip Pulse Oximeter

    FDA cleared for adults, children and adolescents, with a clear OLED screen. Full review

    Amazon UK

  2. Best with an app

    iHealth Air Wireless Pulse Oximeter (PO3M)

    Rechargeable, and logs every reading to your phone over Bluetooth. Full review

    Amazon UK

Each pick shows only in the country where it passed both checks. Right now that is the UK for both. If you are reading in the US, we have not yet found an oximeter on amazon.com that passes both checks. Nearly every oximeter listed there is labeled for sport, aviation or wellness use, and the few cleared ones we found were either rated below our bar by buyers or listed under a different model number from the one the FDA cleared. We will add US picks as soon as one qualifies.

FDA cleared, or “for sport use only”?

The FDA’s own consumer guide on pulse oximeters describes three kinds:

  • Oximeters for medical purposes, “primarily used in hospital settings or doctors’ offices” to help with clinical decisions. These need FDA clearance.
  • A small number of those that are “available over the counter (OTC) following clearance by the FDA.”
  • General wellness and sporting or aviation products, which are not reviewed by the FDA. The agency adds that many people bought these during the COVID-19 pandemic, and that they “are not evaluated by the agency for use in clinical decision-making or determining whether to seek medical intervention.”

So a “sport use only” label is not a technicality. It means nobody outside the company checked the device’s accuracy for medical use.

How to check an oximeter yourself

Every device cleared through the 510(k) route has a public entry in the FDA 510(k) database. Search by product code DQA (oximeters) or by the company name, open the entry, and read the device name: most list the exact model numbers they cover. Then compare that model number with the one on the Amazon listing.

That last step is where many oximeters fall down. Brands sell near-identical devices under slightly different model numbers, and a cleared model’s cousin is not cleared. Several popular listings below were left out for exactly that reason.

Two other things are worth knowing. “FDA approved” on a listing usually means FDA cleared. Clearance (through a 510(k)) is how most oximeters reach the market; approval is a different, rarer process. And many cleared oximeters are cleared for prescription use. The FDA’s device database lists both of our picks as prescription devices in the US. That does not change what the device measures, but it is one more reason the readings belong in a conversation with your doctor rather than in a decision you make alone.

A note for UK readers

In the UK, the regulator is the MHRA, and oximeters for clinical use should carry a CE, CE UKNI or UKCA mark. NHS England’s home oximetry leaflet gives the same advice: if you use a pulse oximeter at home, “make sure it has a CE mark, UKCA mark or CE UKNI mark.” Both picks below are also FDA cleared, a second, separate check.

The MHRA also says it “does not recommend that members of the public use oximeters at home unless they have been advised to do so by a qualified clinician, have been shown how to take an accurate measurement, and they are providing results for clinical review.” If nobody has asked you to monitor your oxygen, that is worth a conversation with your GP before you buy.

The picks

Best overall Passed validation

BLT (Biolight) M70B Fingertip Pulse Oximeter

A fingertip oximeter from Guangdong Biolight Meditech, which also holds FDA clearances for handheld oximeters. The M70B is named in its FDA 510(k) clearance, which covers adults, children and adolescents in hospitals and at home. It shows oxygen saturation, pulse rate and perfusion index on an OLED screen.

Model
M70B
Display
OLED, 6 display modes, 5 brightness levels
Measures
SpO2, pulse rate, perfusion index
Power
2 AAA batteries, over 18 hours of continuous use
Auto off
About 8 seconds after you remove your finger

The proof: FDA 510(k) K151287

Best for

A cleared oximeter for the household, with a screen that is easy to read in any light.

Worth knowing

The listing calls it "FDA approval". The FDA cleared it, which is a different process from approval, and the clearance is for the M70B model only, not the other BLT models sold alongside it.

Check price on Amazon UK

The M70B is one of five Biolight models named in a single FDA clearance, and the clearance covers adults, children and adolescents, in hospital and at home. It shows perfusion index (a measure of signal strength at your fingertip) alongside your oxygen and pulse. The display can be read in four directions and has five brightness levels. Check the model number when you buy: BLT sells other models beside it, and only the M70B is linked here.

Best with an app Passed validation

iHealth Air Wireless Pulse Oximeter (PO3M)

A rechargeable fingertip oximeter that sends each reading over Bluetooth to the free iHealth MyVitals app, so you build a log of your readings without writing them down. The PO3M is the model named in its FDA 510(k) clearance, for spot checks in adults.

Model
PO3M
Display
LED, shows SpO2, pulse rate and perfusion index
Connectivity
Bluetooth 4.0 to the iHealth MyVitals app
Power
Built-in rechargeable battery, USB cable included
In the box
Oximeter, lanyard, carry case, USB cable

The proof: FDA 510(k) K131111

Best for

Anyone who has been asked to keep a record of their readings and would rather the phone kept it.

Worth knowing

The FDA cleared the PO3M for prescription use in adults. On amazon.com the same product is listed as the PO3, which the FDA device database records as a sport and aviation model, so we only recommend the UK listing.

Check price on Amazon UK

If your doctor or nurse has asked you to keep a record of your readings, the iHealth Air saves you the notebook. Each reading goes to the iHealth MyVitals app over Bluetooth, and the battery recharges over USB instead of eating AAA batteries. The FDA cleared the PO3M for spot checks in adults. We only recommend the UK listing: on amazon.com the same product is listed as the PO3, a model the FDA device database records as a sport and aviation product.

A word on skin tone

Pulse oximeters work by shining light through your skin, and the FDA says current evidence “suggests there are some accuracy differences in pulse oximeter performance between individuals with lighter and darker skin pigmentation.” In January 2025 it proposed new testing rules for oximeters used for medical purposes to address this. The UK’s independent review of medical devices reached a similar conclusion in 2024. Those proposed rules are still a draft, and none of the clearances linked here says the device was tested under them. Our guide to pulse oximeter accuracy and skin tone covers what the FDA and the UK review found, and what they advise.

What did not make the list

Several popular oximeters are missing on purpose:

  • Zacurate 500 series, Innovo iP900BP-B and most Wellue fingertip models. The FDA device database records the Zacurate and Innovo models as sporting and aviation oximeters, and the Wellue listings say they are “not a medical device” and “for Sports and Aviation use only”.
  • Nonin TruO2 OTC. Nonin says it is FDA cleared for over-the-counter use, but buyers rated it below our bar on amazon.com when we checked. Nonin’s Onyx Vantage 9590 on amazon.co.uk was also below our bar.
  • Braun Pulse Oximeter 1 (UK). Its model number, YK-81CEU, is close to the YK-81C named in an FDA clearance held by Xuzhou Yongkang, but it is not the same, and we only list an exact match.
  • Contec CMS50D+ and Kinetik Wellbeing (JPD500E). Their makers hold FDA clearances, but for the CMS-50D, CMS-50L and CMS-50DL, and for the JPD-500A. Neither listing is one of those models.
  • Masimo MightySat. Masimo’s MightySat is FDA cleared, including an over-the-counter version, but we could not find it sold on Amazon in either country.

A pulse oximeter is only as useful as the reading you take with it. Before you rely on one, read how to use a pulse oximeter: warm hands, no nail polish, sit still, and wait for the number to settle.

Sources

  1. U.S. Food and Drug Administration, Pulse Oximeter Basics
  2. U.S. Food and Drug Administration, 510(k) Premarket Notification database
  3. U.S. Food and Drug Administration, FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones
  4. Medicines and Healthcare products Regulatory Agency (UK), The use and regulation of pulse oximeters (information for healthcare professionals)
  5. UK Department of Health and Social Care, Equity in medical devices: independent review, summary report
  6. NHS England, Suspected coronavirus (COVID-19): Important information to keep you safe while at home (version 8, April 2022)

Keep reading

How to Use a Pulse Oximeter, and When the NHS and FDA Say to Get Help Warm hands, no nail polish, sit still and wait for a steady number. How to take a pulse oximeter reading the way the FDA describes it, what the numbers on the screen are, and the thresholds NHS England published for when to call 111 or 999. Are Pulse Oximeters Less Accurate on Darker Skin? What the FDA and the UK Review Found The FDA says pulse oximeters show some accuracy differences between lighter and darker skin, and a 2024 UK review found they overestimate oxygen levels more on darker skin. What the regulators found, what the FDA's 2025 draft guidance proposes, and what they advise you to do.