510(k) Report

Devices descending from K973322

39 later devices reach Diapact CRRT through their predicates, nearest generation first.

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