Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905) → NHK — Resuscitator, Manual, Non Self-Inflating

# NHK · Resuscitator, Manual, Non Self-Inflating

_Anesthesiology · 21 CFR 868.5905 · Class 2_

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

## Overview

- **Product Code:** NHK
- **Device Name:** Resuscitator, Manual, Non Self-Inflating
- **Regulation:** [21 CFR 868.5905](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5905)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092687](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K092687.md) | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | A Plus Medical | Nov 23, 2009 | SESE |
| [K020281](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K020281.md) | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | Feb 11, 2002 | SESE |
| [K013308](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K013308.md) | VENTLAB HYPERINFLATION BAG SYSTEM | Ventlab Corp. | Dec 20, 2001 | SESE |
| [K001714](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K001714.md) | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | Mercury Medical | Nov 3, 2000 | SESE |
| [K970785](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K970785.md) | SIMS HYPERINFLATION BAG SYSTEM | Sims | Jun 13, 1997 | SESE |
| [K952214](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K952214.md) | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | Jun 8, 1995 | SESE |
| [K942571](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K942571.md) | HYPER-INFLATION BAG | Med-Plastics Intl., Inc. | Jun 10, 1994 | SESE |
| [K940255](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K940255.md) | HYPERINFLATION BAG SYSTEM | Nutec, Inc. | Feb 17, 1994 | SESE |
| [K894612](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K894612.md) | INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM | Intertech Resources, Inc. | Sep 8, 1989 | SESE |
| [K813317](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NHK/K813317.md) | DISP. HYPERINFLATION BAG SYSTEM | Intec Medical, Inc. | Mar 12, 1982 | SESE |

## Top Applicants

- Intertech Resources, Inc. — 2 clearances
- Ventlab Corp. — 2 clearances
- A Plus Medical — 1 clearance
- Intec Medical, Inc. — 1 clearance
- Med-Plastics Intl., Inc. — 1 clearance

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

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