SGR · Noninvasive Positive Airway Pressure System, Facility Use
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | SGR |
|---|---|
| Device Name | Noninvasive Positive Airway Pressure System, Facility Use |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | Jan 6, 2026 | SESE |
| 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 | Fisher & Paykel Healthcare, Ltd. | Nov 19, 2025 | SESE |
Top Applicants
- Innaccel Technologies Private Limited — 1 clearance
- Fisher & Paykel Healthcare, Ltd. — 1 clearance
