510(k) Report

Devices descending from K120017

14 later devices reach Fresenius 2008 Hemodiaysis Machine with Bibag System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America2012135
+2K133299Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther20140—
+2K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC201310—
+2K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America201311—
+3K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20159Class I
+4K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC201682
+5K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20187Class I
+6K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC202344
+6K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC20223Class I
+7K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…Fresenius Medical Care Renal Therapies Group, LLC202501
+7K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+7K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—
+7K2315345008X Hemodialysis SystemFresenius Medical Care202421
+8K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—