K243917 is an FDA 510(k) clearance for the F&P Optiflow Air/Oxygen Flow Source. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on July 14, 2025, 206 days after receiving the submission on December 20, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K243917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | July 14, 2025 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZR — Mixer, Breathing Gases, Anesthesia Inhalation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5330 |