510(k) Report

Devices descending from K131202

4 later devices reach Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.20200—
+1K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC201822
+2K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.202311
+3K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated20260—