510(k) Report

Devices descending from K944767

4 later devices reach Dialysis Machine with Dialysate Ultrafilter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC20193—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—