510(k) Report

Devices descending from K041683

7 later devices reach B. Braun Bicarbonate Dialysate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052393B. Braun Modified Bicarbonate DialysateB.Braun Medical, Inc.20056—
+2K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products20125—
+3K162887PrismaSATEBaxter Healthcare Corporation20174—
+4K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC20233—
+5K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC202512
+5K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC202421
+6K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC20250—