510(k) Report

Devices descending from K013448

18 later devices reach Prismasate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products20125—
+1K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products200861
+1K041428Accusol Dialysis SolutionBaxter Healthcare Corp20042—
+1K041683B. Braun Bicarbonate DialysateB.Braun Medical, Inc.20047—
+1K034066B.Braun Premixed DialysateB.Braun Medical, Inc.20040—
+1K022913Nxstage Premixed DialysateNxstage Medical, Inc.200212—
+2K162887PrismaSATEBaxter Healthcare Corporation20174—
+2K150966HMB32Haemopharm Biofluids S.R.L.20151—
+2K052393B. Braun Modified Bicarbonate DialysateB.Braun Medical, Inc.20056—
+2K033386Nxstage Pureflow SolutionNxstage Medical, Inc.200310—
+3K233213NxStage PureFlow SolutionNxstage Medical, Inc.20240—
+3K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC20233—
+3K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L.20210—
+3K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc.200481
+4K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC202512
+4K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…Fresenius Medical Care Renal Therapies Group, LLC202421
+4K053286Modification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc.2005014
+5K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…Fresenius Medical Care Renal Therapies Group, LLC20250—