510(k) Report

Devices descending from K021615

8 later devices reach Baxter Accura System, Model 5M5660 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+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
+2K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+2K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+2K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+3K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—