510(k) Report

Devices descending from K864265

41 later devices reach Hemodialysis Bath Concentrate Solutions for Hemodi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard…Aksys, Ltd.2002121
+1K013448PrismasateGambro Renal Products200218—
+1K980659Dryalysate ConcentrateAdvanced Renal Technologies, Inc.19987—
+1K973253Rockwell Medical Supply, LLC. Concentrate Solutions for Acetate DialysateInternational Medical Products, Inc.19970—
+2K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+2K2315345008X Hemodialysis SystemFresenius Medical Care202421
+2K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC202002
+2K171015CitryteDi-Chem, Inc.20170—
+2K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical20165—
+2K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products20125—
+2K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125—
+2K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc.20080—
+2K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products200861
+2K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055—
+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—
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+3K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.202311
+3K210575HDF Assist Mudule, HDF Infusion Set and Substitution FilterNephros20221—
+3K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC20180—
+3K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC201822
+3K162887PrismaSATEBaxter Healthcare Corporation20174—
+3K150966HMB32Haemopharm Biofluids S.R.L.20151—
+3K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.20063—
+3K052393B. Braun Modified Bicarbonate DialysateB.Braun Medical, Inc.20056—
+3K033386Nxstage Pureflow SolutionNxstage Medical, Inc.200310—
+4K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated20260—
+4K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+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—
+4K080919Nxstage Pureflow SLNxstage Medical, Inc.200821
+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
+5K111174Nxstage Pureflow SLNxstage Medical, Inc.201119
+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—
+6K140571Nxstage Pureflow SLNxstage Medical, Inc.201409