510(k) Report

Devices descending from K011368

20 later devices reach Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052253Modification to: Dryac Acid Concentrate Mix for Bicarbonate HemodialysisGambro Renal Products20050—
+1K013448PrismasateGambro Renal Products200218—
+2K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products20125—
+2K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products200861
+2K041428Accusol Dialysis SolutionBaxter Healthcare Corp20042—
+2K041683B. Braun Bicarbonate DialysateB.Braun Medical, Inc.20047—
+2K034066B.Braun Premixed DialysateB.Braun Medical, Inc.20040—
+2K022913Nxstage Premixed DialysateNxstage Medical, Inc.200212—
+3K162887PrismaSATEBaxter Healthcare Corporation20174—
+3K150966HMB32Haemopharm Biofluids S.R.L.20151—
+3K052393B. Braun Modified Bicarbonate DialysateB.Braun Medical, Inc.20056—
+3K033386Nxstage Pureflow SolutionNxstage Medical, Inc.200310—
+4K233213NxStage PureFlow SolutionNxstage Medical, Inc.20240—
+4K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC20233—
+4K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L.20210—
+4K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc.200481
+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
+5K053286Modification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc.2005014
+6K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC20250—