The US Food and Drug Administration granted 510(k) clearance to Masimo’s MightySat Medical fingertip pulse oximeter for over-the-counter use. 

The clearance makes it the first FDA-cleared medical fingertip pulse oximeter available over-the-counter, direct to consumers without a prescription, according to a release from Masimo. The device is powered by Masimo SET pulse oximetry—the same technology relied on by hospitals and clinics to monitor patients and shown to have no clinically significant difference in accuracy or bias between light- and dark-skinned individuals.

The MightySat Medical pulse oximeter now can be purchased on the company’s website, and it will soon be available for purchase at retail and drug stores across the country.

“Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home. On the internet and even in drug stores, they are inundated with a myriad of products that are unreliable, with misleading advertisements about their abilities to provide accurate measurements of oxygen saturation and pulse rate. This clearance of MightySat Medical for consumers eliminates the confusion, placing an FDA-cleared, accurate, reliable, and revolutionary SET pulse oximeter, with technology that hospitals have been using for more than 25 years, directly into their hands,” says Joe Kiani, founder and CEO of Masimo, in a release.

In 2021, the FDA issued a safety communication clarifying that it does not review the accuracy of “health and wellness” pulse oximeters and highlighting the common limitations of both over-the-counter health and wellness and some prescription pulse oximeters—such as difficulty measuring accurately during patient motion, on patients with poor circulation (low perfusion), and on darker skin pigmentation.

“More and more care is moving to the patient’s home. Patients now have the ability to monitor their oxygen levels and pulse rate, which can help them know when they need to seek care,” says Peter Pronovost, MD, PhD, chief quality and clinical transformation officer, University Hospitals, in a release. “Yet to be useful, their pulse oximetry data must be accurate and the accuracy of these devices varies widely. Doctors and nurses rely on Masimo technology in the hospital.”

Masimo MightySat Medical is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin and pulse rate. MightySat Medical is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

MightySat Medical is not intended for the diagnosis or screening of lung disease. Treatment decisions using the device should only be made under the advice of a healthcare provider.

Photo caption: MightySat Medical

Photo credit: Masimo