510(k) Report

Devices descending from K880459

6 later devices reach 480 High-Flow Ultrafiltration Control Dialysate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963440Dialog Dialysis MachineB. Braun Medical AG19985Class I
+2K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+3K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+3K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+3K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+4K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—