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Testing FDA cleared pulse oximeter

Posted at — Sep 23, 2020 by Abishek Muthian

Fake FDA certified pulse oximeters

Ecommerce sites in India are full of pulse oximeters falsely claiming to be FDA certified. If they are actually available in U.S., they don't claim it to be FDA certified and are not listed on FDA's database.

Some of the pulse oximeters try to falsely project quality by prominently claiming to be designed in a Western country, where as they are listed under different brand with poor ratings in the ecommerce websites of the country they claim to be from.

Here is my public service announcement of the same on Twitter.

Naturally, I was asked to name some brands who are perpetrating misinformation. Which I obliged.

Note: After my PSA, some of these sellers have removed the offending FDA certification claims from their listing. But I do have archives of their older listing 1.b, 1.c, 1.d, 2.b.

Genuine FDA certified pulse oximeter

Since then, I was asked by several readers including journalists on how to find genuine pulse oximeters on ecommerce websites. I was convinced that there is no affordable genuine pulse oximeter on ecommerce websites during this pandemic, only way to get one is to buy an expensive medical device and that's what I informed all of them.

But, I wanted to checkout a pulse oximeter from Amazon USA website to see what sensor they are using for technical reasons. I bought 'ATMOKO Pulse Oximeter Finger Oximetry SPO2 Blood Oxygen Saturation Monitor Heart Rate Monitor Rotatable OLED Digital Display Portable with Batteries and Lanyard' for $34.49 (incl. $17.99 shipping+taxes), there was just one item left when I got it and the item description read 'it was not FDA certified'.

But what I received was 'YIMI Life model YM101 fingertip pulse oximeter'.

YIMI Life YM101

To my surprise, YIMI Life YM101 is actually FDA certified.

FDA certification for YIMI  Life YM101

I don't think ATMOKO rebrands YIMI Life YM101 as their listing image was different, perhaps this is an upcoming model waiting to be rebranded or may be this was just lying around for testing, anyways I can't complain for receiving an actual FDA certified pulse oximeter accidentally.

The ATMOKO listing has since been taken down, likely because their inventory is sold out. I couldn't find YIMI Life 101 on Amazon directly, but search results seem to show other brands with the same pulse oximeter. Contact the seller directly and ask them whether it's YIMI Life YM101 before buying.

If you are a reseller, you can find the original manufacturer of YIMI Life YM101 on Alibaba, but it seems like they are selling updated models.

Testing FDA certified Pulse Oximeter

This is a non scientific test, I don’t have a control to reduce the blood haemoglobin levels or a co-oximeter to test it against; but that’s where the FDA certification adds value as they have done tests to state that the device does the job.

Video demo of Testing FDA cleared pulse oximeter
Watch the video on YouTube by clicking on the image.

I'm confident that YIMI Life YM101 indeed does its job.

Disclaimer: I have shared my experiences with finding and testing a pulse oximeter. I'm not suggesting or recommending you to repeat any of my actions without proper medical guidance.

Change log

11-Feb-2022 Changed FDA approved to FDA cleared as 510K is just clearance and not permanent approval.

6-Nov-2021 Removed affiliate links to the products discussed in this content, Not interested in contributing to the growth of mega corporations and earning through them. Blog is now completely reader supported.

16-Oct-2020 Reseller link model name corrected to YM201, YM301 reseller link added.


I strive to write low frequency, High quality content on Health, Product Development, Programming, Software Engineering, DIY, Security, Philosophy and other interests. If you would like to receive them in your email inbox then please consider subscribing to my Newsletter.