510(k) Report

Devices descending from K101715

15 later devices reach Fresenius 2008T Hemodialysis Machine Model 190573 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America2012143
+2K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America2012135
+3K133299Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther20140—
+3K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC201310—
+3K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America201311—
+4K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20159Class I
+5K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC201682
+6K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20187Class I
+7K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC202344
+7K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC20223Class I
+8K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…Fresenius Medical Care Renal Therapies Group, LLC202501
+8K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+8K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—
+8K2315345008X Hemodialysis SystemFresenius Medical Care202421
+9K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—