510(k) Report

Devices descending from K080964

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0933622008 Hemodialysis Sorbent SystemRenal Solutions, Inc.20101—
+1K093964Venofer PumpRenal Solutions, Inc.20102—
+1K093902Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573Fresenius Medical Care North America2010362
+2K1238352008 Hemodialysis Sorbent SystemRenal Solutions, Inc.20130—
+2K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care2011191
+2K103564Venofer PumpRenal Solutions, Inc.20111—
+2K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente2010151
+3K121497Venofer PumpRenal Solutions, Inc.201201
+3K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America2012143
+3K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America2011184
+4K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America2012135
+4K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente2012174
+5K140866Tablo ConsoleHome Dialysis Plus201416—
+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—
+6K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+6K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20159Class I
+6K150880Tablo Console with Wireless CapabilityOutset Medical201511—
+7K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+7K160881Tablo ConsoleOutset Medical, Inc.201610—
+7K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC201682
+8K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+8K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—
+8K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+8K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+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
+9K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+9K210782Tablo CartridgeOutset Medical, Inc.20211—
+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—
+10K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+10K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+10K2315345008X Hemodialysis SystemFresenius Medical Care202421
+10K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+11K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+11K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+11K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+12K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—