Cleared Special

HydraGuard 10 UltraFilter

K161467 · Nephros, Inc. · Gastroenterology & Urology

Dec 2016

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K161467 is an FDA 510(k) clearance for the HydraGuard 10 UltraFilter, a System, Water Purification, General Medical Use (Class II — Special Controls, product code NHV), submitted by Nephros, Inc. (River Edge, US). The FDA issued a Cleared decision on December 22, 2016, 209 days after receiving the submission on May 27, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number	K161467 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2016
Decision Date	December 22, 2016
Days to Decision	209 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	NHV — System, Water Purification, General Medical Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5665
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.