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) → ONZ — Mechanical Ventilator

# ONZ · Mechanical Ventilator

_Anesthesiology · 21 CFR 868.5895 · Class 2_

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

## Overview

- **Product Code:** ONZ
- **Device Name:** Mechanical Ventilator
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K152664](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K152664.md) | TAV System | New Aera, Inc. | Dec 2, 2016 | SESE |
| [K131562](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K131562.md) | BREATHE NIOV VENTILATION SYSTEM | Breathe Technologies | Mar 6, 2014 | SESE |
| [K103345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K103345.md) | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Feb 11, 2011 | SESE |
| [K102525](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K102525.md) | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Dec 2, 2010 | SESE |
| [K100528](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K100528.md) | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Breathe Technologies, Inc. | Apr 23, 2010 | SESE |
| [K082982](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/ONZ/K082982.md) | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | Jul 20, 2009 | SESE |

## Top Applicants

- Breathe Technologies, Inc. — 4 clearances
- Breathe Technologies — 1 clearance
- New Aera, Inc. — 1 clearance

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

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