FDA Product Code NHV: System, Water Purification, General Medical Use
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.
Leading manufacturers include Nephros, Inc., Pall International Sarl and Ecolab, Inc..
12
Total
12
Cleared
204d
Avg days
2002
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
128d
recently vs 210d historically
FDA 510(k) Cleared System, Water Purification, General Medical Use Devices (Product Code NHV)
12 devices
Cleared
Sep 09, 2026
QF10
E.A.M Benelux B.V
Gastroenterology & Urology
128d
Cleared
Jun 02, 2023
i3 ONE (203100-S)
I3 Membrane GmbH
Gastroenterology & Urology
267d
Cleared
Oct 25, 2019
FILTRAY 2G Disposable Water Filters
Aqua-Tools
Gastroenterology & Urology
134d
Cleared
Mar 29, 2019
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
Ecolab, Inc.
Gastroenterology & Urology
231d
Cleared
Jun 29, 2018
Ecolab POU Water Filter
Ecolab, Inc.
Gastroenterology & Urology
273d
Cleared
Jun 01, 2017
Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
Pall International Sarl
Gastroenterology & Urology
161d
Cleared
Dec 22, 2016
HydraGuard 10 UltraFilter
Nephros, Inc.
Gastroenterology & Urology
209d
Cleared
Oct 21, 2016
NOSOGARD FILTERS
Evoqua Water Technologies, LLC
Gastroenterology & Urology
295d
Cleared
Jun 10, 2016
Pall-Aquasafe Water Filter
Pall International Sarl
Gastroenterology & Urology
196d
Cleared
Apr 08, 2016
Nephros S100
Nephros, Inc.
Gastroenterology & Urology
165d
Cleared
Oct 24, 2014
NEPHROS DSU-H, NEPHROS SSU-H
Nephros, Inc.
Gastroenterology & Urology
119d
Cleared
May 07, 2002
MAINSTREAM WATER PURIFICATION DEVICE
Prismedical Corp.
Gastroenterology & Urology
265d
About Product Code NHV - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code NHV since 2002, with 12 receiving FDA clearance (average review time: 204 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - NHV Product Code
Recent submissions under NHV have taken an average of 128 days to reach a decision - down from 210 days historically, suggesting improved FDA processing for this classification.
NHV devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →