510(k) Report

Devices descending from K140866

16 later devices reach Tablo Console through their predicates, nearest generation first.

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