Masimo Corporation - FDA 510(k) Cleared Devices

Masimo Corporation, is an American health technology and consumer electronics company headquartered in Irvine, California. The company develops patient monitoring devices, non-invasive sensors, and related software platforms for hospital and home settings.

Masimo has received 83 FDA 510(k) clearances from 85 total submissions since its first clearance in 2004. The company's regulatory focus centers on Anesthesiology devices, which represent 74% of submissions. Latest clearance activity in 2025 demonstrates continued regulatory engagement.

Recent cleared devices span Anesthesiology, Cardiovascular, and General & Plastic Surgery categories. Masimo specializes in patient monitoring technologies, including regional oximetry, wearable sensors, and integrated clinical platforms used across acute care and consumer markets.

Explore the complete regulatory record by reviewing individual device names, product codes, and clearance dates in the database.

8 devices have linked clinical trials registered on ClinicalTrials.gov.