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# Masimo Medical Watch Cleared by FDA
- URL: https://www.fdaweb.com/masimo-medical-watch-cleared-by-fda/
- Published: 2023-11-22T12:00:00.000Z
- Updated: 2026-09-14T14:16:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155852

FDA has cleared a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use. The company says the watch was developed to be lifestyle-friendly to provide users with “untethered continuous pulse oximetry as they move about their lives – no matter where they are.”

The device uses the company’s integrated Masimo MW-1 sensor, hardware, and software module, which “incorporates over 30 years of Signal Extraction Technology pulse oximetry knowledge into a single wearable module,” the company says. “It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals.”