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).
Recent Cleared Devices (2 of 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
- Fisher & Paykel Healthcare, Ltd. — 1 clearance
- Innaccel Technologies Private Limited — 1 clearance
