510(k) Report

Devices descending from K955592

38 later devices reach Cobe Centrysystem 14 Pes Hemodialyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982413Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/FiltersGambro Healthcare19990—
+1K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare199936—
+2K050603Olpur Dialyzer, Model HD 190Nephros, Inc.20056—
+2K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…Gambro Renal Products20059—
+2K030592Gambro Polyflux, Model 140H, 170H, 210HGambro Renal Care Products200319—
+2K014152Nxstage Cartridge ExpressNxstage Medical, Inc.20027—
+2K994390Gambro Polyflux 17R, Capillary Dialyzer/ FilterGambro Healthcare200010—
+3K220721FX 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—
+3K213639Revaclear 500, Revaclear 400, Revaclear 300Baxter Healthcare Corporation20220—
+3K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201—
+3K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22Bellco Srl20201—
+3K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+3K060195Gambro Polyflux HD-C4 Capillary Dialyzer/Filter for Single UseGambro Renal Products200622
+3K051520Gambro Polyflux Hemodialyzer, Model 6HGambro Renal Products20051—
+3K040255Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single UseGambro Renal Products, Inc.200410—
+3K032356Nxstage System One with Cartridge ExpressNxstage Medical, Inc.20036—
+4K260533Elisio™-HNipro Medical Corporation20260—
+4K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+4K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252—
+4K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241—
+4K2315345008X Hemodialysis SystemFresenius Medical Care202421
+4K231406ClearumTM HSBellco Srl20230—
+4K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+4K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+4K130039Revaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc.201307
+4K072232Gambro Polyflux Hemodialyzer, Model: HD-C4 SmallGambro Renal Products, Inc.200711
+4K050727Modification to Nxstage Cartridge ExpressNxstage Medical, Inc.20055—
+5K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC20260—
+5K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC20260—
+5K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—
+5K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+5K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+5K061837Nxstage Cartridge ExpressNxstage Medical, Inc.200641
+6K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+6K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc.20240—
+6K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc.201901
+6K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+6K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—