510(k) Report

Devices descending from K041005

4 later devices reach Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets through their predicates, nearest generation first.

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