NHV · Class II · 21 CFR 876.5665

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 I3 Membrane GmbH.

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
1–11 of 11
Cleared Jun 02, 2023
i3 ONE (203100-S)
K222727
I3 Membrane GmbH
Gastroenterology & Urology · 267d

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.

NHV devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →