Clearance Summary
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) received FDA 510(k) clearance under submission number K253479, sponsored by Fisher & Paykel Healthcare, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-12-19.
- Submission: K253479
- Applicant / Sponsor: Fisher & Paykel Healthcare, Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code BTT and 21 CFR 868.5450, within the Anesthesiology review panel as a Class II device.