510(k) Report

Devices descending from K882564

5 later devices reach Renalin Cold Sterilant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962959Peracidin Dialyzer Reprocessing ConcentrateHdc Medical, Inc.19984—
+2K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC201031
+3K140984TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC20150—
+3K141213Ameriwater Ozone Disinfection SystemAmeriwater20140—
+3K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…Ameriwater20140—