510(k) Report

Devices descending from K231534

2 later devices reach 5008X Hemodialysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+2K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—