510(k) Report

Devices descending from K963440

5 later devices reach Dialog Dialysis Machine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+2K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+2K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+2K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+3K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—