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) → NQY — Ventilator, Continuous, Minimal Ventilatory Support, Home Use

# NQY · Ventilator, Continuous, Minimal Ventilatory Support, Home Use

_Anesthesiology · 21 CFR 868.5895 · Class 2_

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

## Overview

- **Product Code:** NQY
- **Device Name:** Ventilator, Continuous, Minimal Ventilatory Support, Home Use
- **Regulation:** [21 CFR 868.5895](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5895)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## 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 (0 of 0)

_No cleared devices on record._

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
