510(k) Report

Devices descending from K981043

5 later devices reach Dialysol-Acid Concentrate Liquid, Granusol-Acid Concentrate Powder… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC202016
+1K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate…Fresenius Medical Care Renal Therapies Group, LLC202011
+1K071387Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LBFresenius Medical Care North America20070Class I
+2K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC20260—
+2K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC202202