FDA product code NHK: Resuscitator, Manual, Non Self-Inflating
NHK is the FDA product code for resuscitator, manual, non self-inflating. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel. FDA has cleared 10 510(k) submissions under NHK, from 8 different applicants. The average 510(k) review took 65 days (median 64).
Definition
A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.
Classification
| Field | Value |
|---|---|
| Device name | Resuscitator, Manual, Non Self-Inflating |
| Device class | Class II |
| Regulation | 21 CFR 868.5905 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every NHK clearance
Top NHK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventlab Corp. | 2 | 2002-02-11 |
| Intertech Resources, Inc. | 2 | 1995-06-08 |
| A Plus Medical | 1 | 2009-11-23 |
| Mercury Medical | 1 | 2000-11-03 |
| Sims | 1 | 1997-06-13 |
3 more applicants have NHK clearances. See the full list in Caduvo.
Most recent NHK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092687 | A Plus Medical | VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER | 2009-11-23 | 83 |
| K020281 | Ventlab Corp. | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | 2002-02-11 | 14 |
| K013308 | Ventlab Corp. | VENTLAB HYPERINFLATION BAG SYSTEM | 2001-12-20 | 77 |
| K001714 | Mercury Medical | MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 | 2000-11-03 | 151 |
| K970785 | Sims | SIMS HYPERINFLATION BAG SYSTEM | 1997-06-13 | 101 |
Recalls for NHK devices
openFDA lists no recalls for product code NHK.
Frequently asked questions
What is FDA product code NHK?
NHK is the FDA product code for resuscitator, manual, non self-inflating. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel.
What device class is NHK?
Class II, regulation 21 CFR 868.5905. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHK?
Across 10 cleared submissions the average was 65 days from receipt to decision (median 64).
Which companies have the most NHK clearances?
Ventlab Corp. (2); Intertech Resources, Inc. (2); A Plus Medical (1); Mercury Medical (1); Sims (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHK
- Run a recall and safety report across every NHK manufacturer
- Watch product code NHK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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