510(k) Report

Devices descending from K011221

2 later devices reach Prisma HF 1000 Set, Prisma HF 1000 Pre-Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+2K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—