510(k) Report

Devices descending from K922005

9 later devices reach Granulyte Dialysate Concentrate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030497Fresenius Naturalyte Granuflo Dry Acid Concentrate 10XX Series, 24XX Series, 30XX SeriesFresenius Medical Care20031Class I
+1K980659Dryalysate ConcentrateAdvanced Renal Technologies, Inc.19987—
+2K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC202002
+2K171015CitryteDi-Chem, Inc.20170—
+2K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical20165—
+3K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.202311
+3K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon…Global Scientific Technologies, LLC20180—
+3K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC201822
+4K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated20260—