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# FDA Clears Masimo OTC Pulse Oximeter
- URL: https://www.fdaweb.com/fda-clears-masimo-otc-pulse-oximeter/
- Published: 2024-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:22:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156345

FDA has cleared a Masimo 510(k) for its MightySat Medical, an over-the-counter fingertip pulse oximeter. The company says it uses the same technology “relied on by hospitals and clinics around the world to monitor more than 200 million patients every year, and shown to have no clinically significant difference in accuracy or bias between light- and dark-skinned individuals.”