510(k) Report

Devices descending from K120823

8 later devices reach BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140841Tablo CartridgeHome Dialysis Plus20147—
+2K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20203—
+2K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+3K210782Tablo CartridgeOutset Medical, Inc.20211—
+3K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.20212—
+4K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+4K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+4K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—