Clearance Summary
Masimo O3 Regional Oximeter received FDA 510(k) clearance under submission number K243324, sponsored by Masimo Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-07-17.
- Submission: K243324
- Applicant / Sponsor: Masimo Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2025-07-17
Classification & Regulation
This clearance is catalogued under FDA product code MUD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.