510(k) Report

Devices descending from K233950

2 later devices reach pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC202512
+2K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC20250—