Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895) → SGR — Noninvasive Positive Airway Pressure System, Facility Use

# SGR · Noninvasive Positive Airway Pressure System, Facility Use

_Anesthesiology · 21 CFR 868.5895 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SGR

## Overview

- **Product Code:** SGR
- **Device Name:** Noninvasive Positive Airway Pressure System, Facility Use
- **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SGR/K251165.md) | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | Jan 6, 2026 | SESE |
| [K250651](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SGR/K250651.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SGR](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/SGR)

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