510(k) Report

Devices descending from K843963

5 later devices reach Dialysate Concentrate for Hemodialysis-Liquid/Powd through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Dialysis Medical Solutions, LLC201441
+2K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.20200—
+2K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC201822
+3K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.202311
+4K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated20260—