510(k) Report

Devices descending from K954527

6 later devices reach Rockwell Medical Supply LLC Hemodialysis Concentrate Solutions & Powders through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131202Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X)…Dialysis Medical Solutions, LLC201441
+1K090002Acid Concentrate 45X (2.0K, 3.1CA), Model 5M8001A, Acid Concentrate 45X (2.0K, 2.5CA)…Baxter Healthcare Corp20090—
+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—