510(k) Report

Devices descending from K113427

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente2012174
+2K140866Tablo ConsoleHome Dialysis Plus201416—
+3K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+3K150880Tablo Console with Wireless CapabilityOutset Medical201511—
+4K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+4K160881Tablo ConsoleOutset Medical, Inc.201610—
+5K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+5K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—
+5K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+5K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+6K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+6K210782Tablo CartridgeOutset Medical, Inc.20211—
+7K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+7K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+7K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+8K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+8K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+9K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—