510(k) Report

Devices descending from K111639

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113427Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America2011184
+2K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente2012174
+3K140866Tablo ConsoleHome Dialysis Plus201416—
+4K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+4K150880Tablo Console with Wireless CapabilityOutset Medical201511—
+5K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+5K160881Tablo ConsoleOutset Medical, Inc.201610—
+6K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+6K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—
+6K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+6K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+7K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+7K210782Tablo CartridgeOutset Medical, Inc.20211—
+8K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+8K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+8K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+9K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+9K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+10K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—