510(k) Report

Devices descending from K140841

7 later devices reach Tablo Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+1K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+2K210782Tablo CartridgeOutset Medical, Inc.20211—
+2K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+3K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+3K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+3K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—