510(k) Report

Devices descending from K163530

4 later devices reach PrisMax Control Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—
+1K190910PrisMax System Version 2Baxter Healthcare Corp201925
+2K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+2K193482PrisMax System Version 3Baxter Healthcare Corporation202002