Clearance Summary
AirFit F20 Mask System; AirFit F20 NM Mask System received FDA 510(k) clearance under submission number K242547, sponsored by Resmed Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-05-19.
- Submission: K242547
- Applicant / Sponsor: Resmed Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2025-05-19
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.