510(k) Report

Devices descending from K010667

22 later devices reach Gambro Polyflux 24S, Gambro Polyflux 24R through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051187Rexeed Series DialyzersAsahi Kasei Medical Co., Ltd.2005201
+1K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products20059—
+2K220721FX 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—
+2K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201—
+2K153344Asahi REXEED-S Series DialyzerAsahi Kasei Medical Co., Ltd.20150—
+2K121409Asahi Rexeed-SX/LX Series DialyzerAsahi Kasei Medical Co., Ltd.20130—
+2K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America2008163
+2K082515Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXAsahi Kasei Medical Co., Ltd.200817
+3K260533Elisio™-HNipro Medical Corporation20260—
+3K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+3K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252—
+3K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241—
+3K123262Optiflux Ultra DialyzerFresenius Medical Care North America201413—
+3K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+4K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC20260—
+4K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC20260—
+4K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—
+4K152367Optiflux dialyzerFresenius Medical Care North America2015121
+4K140191Elisio-H HemodialyzerNipro Medical Corporation20141—
+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