510(k) K141731

NEPHROS DSU-H, NEPHROS SSU-H by Nephros, Inc. — Product Code NHV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 24, 2014
Date Received: June 27, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Water Purification, General Medical Use
Device Class: Class II
Regulation Number: 876.5665
Review Panel: GU
Submission Type

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.

Other clearances by Nephros, Inc.

K210575 — HDF Assist Mudule, HDF Infusion Set and Substitution Filter (May 13, 2022)
K161304 — EndoPur Filter (March 2, 2017)
K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
K153084 — Nephros S100 (April 8, 2016)
K112314 — NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER (April 27, 2012)
K110285 — NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER (July 14, 2011)
K090885 — NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER (June 29, 2009)
K050603 — OLPUR DIALYZER, MODEL HD 190 (June 9, 2005)

Other clearances for product code NHV

K222727 — i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (June 2, 2023)
K191563 — FILTRAY 2G Disposable Water Filters (October 25, 2019)
K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Eco (March 29, 2019)
K173164 — Ecolab POU Water Filter (June 29, 2018)
K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Fau (June 1, 2017)
K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
K153784 — NOSOGARD FILTERS (October 21, 2016)
K153434 — Pall-Aquasafe Water Filter (June 10, 2016)
K153084 — Nephros S100 (April 8, 2016)
K012716 — MAINSTREAM WATER PURIFICATION DEVICE (May 7, 2002)