510(k) Report

Devices descending from K032431

8 later devices reach Prisma M60/M100 Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—
+1K070222Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America20070—
+1K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+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—