510(k) Report

Devices descending from K001283

34 later devices reach Lifemate Hemofiltration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012510Modification to: Lifemate Hemofiltration SystemNxstage Medical, Inc.200133—
+2K020858Nxstage Therapy SystemNxstage Medical, Inc.200232—
+3K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc.200711
+3K030470Nxstage System OneNxstage Medical, Inc.200329—
+4K140623Nxstage Express Fluid WarmerNxstage Medical, Inc.20140—
+4K041424Nxstage System OneNxstage Medical, Inc.200428—
+5K050525Nxstage System OneNxstage Medical, Inc.2005272
+6K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200626—
+7K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+7K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+7K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation20130—
+7K122343Pureflux-H HemodialyzerNipro Medical Corporation20130—
+7K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200920—
+7K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America2008163
+8K123262Optiflux Ultra DialyzerFresenius Medical Care North America201413—
+8K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+8K122347Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation20135—
+8K093120Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170Baxter Healthcare Corporation - Renal Division20106—
+9K152367Optiflux dialyzerFresenius Medical Care North America2015121
+9K140191Elisio-H HemodialyzerNipro Medical Corporation20141—
+9K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation20133—
+10K260533Elisio™-HNipro Medical Corporation20260—
+10K192707Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC20200—
+10K192928Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group, LLC20200—
+10K162488Optiflux dialyzerFresenius Medical Care North America201794
+10K160444FB-U HemodialyzerNipro Medical Corporation20170—
+11K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC20260—
+11K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX…Fresenius Medical Care Renal Therapies Group, LLC20236—
+11K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201—
+12K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+12K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252—
+12K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241—
+13K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC20260—
+13K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—