510(k) Report

Devices descending from K940601

23 later devices reach Gambro Bicart 720G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202508Hemo-Lyte C CartridgeDi-Chem, Inc.20220—
+1K013724BicartGambro Renal Products200221—
+1K990010Althin Medical AB Altracart IIAlthin Medical AB19990—
+2K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development20240—
+2K221652NikkicartRenal Care Dialysis Solutions, S.A. DE C.V.20230—
+2K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente2010151
+2K072760Solcart BB. Braun Medizintechnologie GmbH20082—
+3K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America2012143
+3K102194Solcart BB. Braun Avitum AG20111—
+4K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America2012135
+5K133299Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther20140—
+5K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC201310—
+5K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America201311—
+6K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20159Class I
+7K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC201682
+8K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20187Class I
+9K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC202344
+9K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC20223Class I
+10K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…Fresenius Medical Care Renal Therapies Group, LLC202501
+10K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+10K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—
+10K2315345008X Hemodialysis SystemFresenius Medical Care202421
+11K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—