510(k) Report

Devices descending from K900105

44 later devices reach Cobe Spectra Blood Component Separator Therapeutic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc.201221
+1K973322Diapact CRRTB.Braun Medical, Inc.199839—
+1K953681Haemonetics Therapeutic Plasma Exchange SetHaemonetics Corp.19960—
+2K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.20141—
+2K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+2K030470Nxstage System OneNxstage Medical, Inc.200329—
+2K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+3K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160—
+3K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+3K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+3K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+3K041424Nxstage System OneNxstage Medical, Inc.200428—
+4K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+4K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+4K050525Nxstage System OneNxstage Medical, Inc.2005272
+4K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+5K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—
+5K062079Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200626—
+6K160558Rapido Hollow-Fibre DialyzersBellco Srl20160—
+6K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+6K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation20130—
+6K122343Pureflux-H HemodialyzerNipro Medical Corporation20130—
+6K083778Xenium XPH, Models 110, 130, 150, 170, 190 and 210Baxter Healthcare Corporation200920—
+6K082414Optiflux F250NR, Model 0500325EFresenius Medical Care North America2008163
+7K123262Optiflux Ultra DialyzerFresenius Medical Care North America201413—
+7K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+7K122347Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation20135—
+7K093120Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170Baxter Healthcare Corporation - Renal Division20106—
+8K152367Optiflux dialyzerFresenius Medical Care North America2015121
+8K140191Elisio-H HemodialyzerNipro Medical Corporation20141—
+8K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation20133—
+9K260533Elisio™-HNipro Medical Corporation20260—
+9K192707Optiflux F180NR DialyzerFresenius Medical Care Renal Therapies Group, LLC20200—
+9K192928Optiflux Enexa F500 DialyzerFresenius Medical Care Reanal Therapies Group, LLC20200—
+9K162488Optiflux dialyzerFresenius Medical Care North America201794
+9K160444FB-U HemodialyzerNipro Medical Corporation20170—
+10K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC20260—
+10K220721FX 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—
+10K203062Optiflux Series of Dialyzers F160NR, F180NR, F200NRFresenius Medical Care Renal Therapies Group, LLC20201—
+11K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+11K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120…Fresenius Medical Care Renal Therapies Group, LLC20252—
+11K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC20241—
+12K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC20260—
+12K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—