Clearance Summary
Optiflow Oxygen Kit (AA484J) received FDA 510(k) clearance under submission number K262268, sponsored by Fisher and Paykel Healthcare Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-08-27.
- Submission: K262268
- Applicant / Sponsor: Fisher and Paykel Healthcare Limited
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5450
- Decision date: 2026-08-27
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.