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) → NOU — Continuous, Ventilator, Home Use

# NOU · Continuous, Ventilator, Home Use

_Anesthesiology · 21 CFR 868.5895 · Class 2_

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

## Overview

- **Product Code:** NOU
- **Device Name:** Continuous, Ventilator, 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233452](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K233452.md) | Vivo 45 LS | Breas Medical AB | Jan 13, 2025 | SESE |
| [K193586](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K193586.md) | Vivo 45 LS | Breas Medical AB | Jan 27, 2021 | SESE |
| [K160481](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K160481.md) | Vivo 60 | Breas Medical AB | Nov 9, 2016 | SESE |
| [K123144](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K123144.md) | VIVO 50 | Ge Healthcare, Breas Medical AB | Jun 18, 2013 | SESE |
| [K034032](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K034032.md) | PLV CONTINUUM VENTILATOR, MODEL P2000 | Respironics California, Inc. | Mar 16, 2004 | SESE |
| [K022750](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K022750.md) | PLV CONTINUUM VENTILATOR, MODEL P1000 | Respironics California, Inc. | Nov 20, 2003 | SESE |
| [K021981](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NOU/K021981.md) | IVENT 201 PORTABLE VENTILATOR | Versamed , Ltd. | Aug 13, 2003 | SESE |

## Top Applicants

- Breas Medical AB — 3 clearances
- Respironics California, Inc. — 2 clearances
- Ge Healthcare, Breas Medical AB — 1 clearance
- Versamed , Ltd. — 1 clearance

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

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