510(k) Report

Devices descending from K033386

10 later devices reach Nxstage Pureflow Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233213NxStage PureFlow SolutionNxstage Medical, Inc.20240—
+1K042045Nxstage Pureflow-B SolutionNxstage Medical, Inc.200481
+2K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products200861
+2K053286Modification to: Nxstage Pureflow-B SolutionNxstage Medical, Inc.2005014
+3K162887PrismaSATEBaxter Healthcare Corporation20174—
+3K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products20125—
+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—