510(k) Report

Devices descending from K182367

3 later devices reach DIASAFEplusUS through their predicates, nearest generation first.

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