510(k) Report

Devices descending from K210661

2 later devices reach SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…Quanta Dialysis Technologies, Ltd.20240—
+1K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.20220—