510(k) Report

Devices descending from K030592

19 later devices reach Gambro Polyflux, Model 140H, 170H, 210H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213639Revaclear 500, Revaclear 400, Revaclear 300Baxter Healthcare Corporation20220—
+1K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl20201—
+1K060195Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products200622
+1K051520Gambro Polyflux Hemodialyzer, Model 6HGambro Renal Products20051—
+1K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products20059—
+1K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.200410—
+2K231406ClearumTM HSBellco Srl20230—
+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—
+2K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+2K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc.201307
+2K072232Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallGambro Renal Products, Inc.200711
+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—
+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—