K250651 is an FDA 510(k) clearance for the OptiPAP Junior Flexi Tube US (OPTIPAPFUS). This device is classified as a Noninvasive Positive Airway Pressure System, Facility Use (Class II - Special Controls, product code SGR).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on November 19, 2025, 260 days after receiving the submission on March 4, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895. To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure..
| 510(k) Number | K250651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2025 |
| Decision Date | November 19, 2025 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | SGR — Noninvasive Positive Airway Pressure System, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |
| Definition | To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure. |