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 Ecolab, Inc., I3 Membrane GmbH and Aqua-Tools.
11
Total
11
Cleared
210d
Avg days
2002
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared System, Water Purification, General Medical Use Devices (Product Code NHV)
11 devices
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
About Product Code NHV - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code NHV since 2002, with 11 receiving FDA clearance (average review time: 210 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.