Masimo Corp. - FDA 510(k) Cleared Devices

Masimo Corp., is an American health technology 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 28 FDA 510(k) clearances from 28 total submissions since its first clearance in 1997. The company's regulatory submissions have focused exclusively on Anesthesiology devices, including pulse oximetry sensors, adaptor cables, and monitoring modules. The latest clearance on record dates to 2004, reflecting the company's historical regulatory activity in this category.

The company's cleared devices include pulse oximetry sensors, transflectance sensors, and pulse oximeter modules designed for anesthesia monitoring and patient care. These products represent core technologies in non-invasive patient monitoring.

Explore the complete regulatory record, including device names, product codes, and clearance dates, in the database below.