510(k) Report

Devices descending from K002045

12 later devices reach Water Purification System for Hemodialysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042089NX Stage Water Purification SystemNxstage Medical, Inc.20040—
+1K012716Mainstream Water Purification DevicePrismedical Corp.200210—
+2K153784Nosogard FiltersEvoqua Water Technologies, LLC20164—
+2K141731Nephros Dsu-H, Nephros Ssu-HNephros, Inc.20149—
+3K191563FILTRAY 2G Disposable Water FiltersAqua-Tools20191—
+3K173164Ecolab POU Water FilterEcolab, Inc.20181—
+3K153434Pall-Aquasafe Water FilterPall International Sarl20164—
+3K153084Nephros S100Nephros, Inc.20162—
+4K261470QF10E.A.M Benelux B.V20260—
+4K222727i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)I3 Membrane GmbH20230—
+4K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…Ecolab, Inc.20190—
+4K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International Sarl20170—