510(k) Report

Devices descending from K030974

27 later devices reach Exeltra High Flux Dialyzer, Models 150 & 170 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160444FB-U HemodialyzerNipro Medical Corporation20170—
+1K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200626—
+2K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+2K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+2K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation20130—
+2K122343Pureflux-H HemodialyzerNipro Medical Corporation20130—
+2K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200920—
+2K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America2008163
+3K123262Optiflux Ultra DialyzerFresenius Medical Care North America201413—
+3K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+3K122347Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation20135—
+3K093120Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170Baxter Healthcare Corporation - Renal Division20106—
+4K152367Optiflux dialyzerFresenius Medical Care North America2015121
+4K140191Elisio-H HemodialyzerNipro Medical Corporation20141—
+4K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation20133—
+5K260533Elisio™-HNipro Medical Corporation20260—
+5K192707Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC20200—
+5K192928Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group, LLC20200—
+5K162488Optiflux dialyzerFresenius Medical Care North America201794
+6K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC20260—
+6K220721FX 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—
+6K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201—
+7K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+7K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252—
+7K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241—
+8K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC20260—
+8K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—