FDA product code NHV: System, Water Purification, General Medical Use
NHV is the FDA product code for system, water purification, general medical use. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under NHV, 2 in the last five years, from 8 different applicants. The average 510(k) review took 204 days (median 202); 128 days on average over the last three years.
Definition
The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.
Classification
| Field | Value |
|---|---|
| Device name | System, Water Purification, General Medical Use |
| Device class | Class II |
| Regulation | 21 CFR 876.5665 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NHV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 161 |
| 2018 | 1 | 273 |
| 2019 | 2 | 182 |
| 2023 | 1 | 267 |
| 2026 | 1 | 128 |
Compare with all 510(k) review times · Search every NHV clearance
Top NHV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nephros, Inc. | 3 | 2016-12-22 |
| Ecolab, Inc. | 2 | 2019-03-29 |
| Pall International Sarl | 2 | 2017-06-01 |
| E.A.M Benelux B.V | 1 | 2026-09-09 |
| I3 Membrane GmbH | 1 | 2023-06-02 |
3 more applicants have NHV clearances. See the full list in Caduvo.
Most recent NHV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261470 | E.A.M Benelux B.V | QF10 | 2026-09-09 | 128 |
| K222727 | I3 Membrane GmbH | i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) | 2023-06-02 | 267 |
| K191563 | Aqua-Tools | FILTRAY 2G Disposable Water Filters | 2019-10-25 | 134 |
| K182164 | Ecolab, Inc. | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | 2019-03-29 | 231 |
| K173164 | Ecolab, Inc. | Ecolab POU Water Filter | 2018-06-29 | 273 |
Recalls for NHV devices
openFDA lists no recalls for product code NHV.
Frequently asked questions
What is FDA product code NHV?
NHV is the FDA product code for system, water purification, general medical use. It is a Class II device, regulated under 21 CFR 876.5665 and reviewed by the Gastroenterology and Urology panel.
What device class is NHV?
Class II, regulation 21 CFR 876.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHV?
Across 12 cleared submissions the average was 204 days from receipt to decision (median 202).
Which companies have the most NHV clearances?
Nephros, Inc. (3); Ecolab, Inc. (2); Pall International Sarl (2); E.A.M Benelux B.V (1); I3 Membrane GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHV
- Run a recall and safety report across every NHV manufacturer
- Watch product code NHV 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times