510(k) Report

Devices descending from K924437

10 later devices reach Hemospal Kit B22 / Multiflow 60 Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980386Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22…Gambro Healthcare199991
+2K070222Fresenius Renal Acute Care (Rac 100) Filter, Model 0500610NFresenius Medical Care North America20070—
+2K032431Prisma M60/M100 SetsGambro, Inc.200386
+3K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—
+3K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+3K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+4K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+4K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+4K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+5K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—