Noninvasive Positive Airway Pressure System, Facility Use
Anesthesiology · 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.
Recent MDR events
4 adverse event reports on file
- F&P OptiPAP JuniorJul 29, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02310
- F&P OptiPAP JuniorJul 29, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02309
- F&P OptiPAP JuniorJul 28, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02304
- F&P OPTIPAP JUNIORJun 25, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02017
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
2 clearances for this product code
- Innaccel Technologies Private LimitedJan 6, 2026
K251165 · Saans (F4-01-00-000-000)
- Fisher & Paykel Healthcare, Ltd.Nov 19, 2025
K250651 · OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun