510(k) Report

Devices descending from K093902

36 later devices reach Modification to:Fresenius 2008T Hemodialysis Machine, Model 190573 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111639Fresenius 2008T Hemodialysis MachineFresenius Medical Care2011191
+1K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente2010151
+2K120017Fresenius 2008 Hemodiaysis Machine with Bibag SystemFresenius Medical Care North America2012143
+2K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America2011184
+3K121341Fresenius 2008T Hemodialysis Machine with Bibag SystemFresenius Medical Care North America2012135
+3K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente2012174
+4K140866Tablo ConsoleHome Dialysis Plus201416—
+4K133299Acetic Acid Wand, Acid Wand Assembly, Bicarbonate Wand AssemblyFresenius Medical Care, North America - Renal Ther20140—
+4K1319082008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)Fresenius Medical Care Renal Therapies Group, LLC201310—
+4K1240352008K@Home Hemodialysis MachineFresenius Medical Care North America201311—
+5K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+5K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20159Class I
+5K150880Tablo Console with Wireless CapabilityOutset Medical201511—
+6K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+6K160881Tablo ConsoleOutset Medical, Inc.201610—
+6K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC201682
+7K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+7K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—
+7K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+7K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+7K1739722008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC20187Class I
+8K2311252008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC202344
+8K2229522008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC20223Class I
+8K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+8K210782Tablo CartridgeOutset Medical, Inc.20211—
+9K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…Fresenius Medical Care Renal Therapies Group, LLC202501
+9K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+9K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—
+9K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+9K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+9K2315345008X Hemodialysis SystemFresenius Medical Care202421
+9K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+10K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+10K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+10K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+11K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—