510(k) Report

Devices descending from K041163

4 later devices reach Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.20250—
+1K161844Matrix Pre-Treatment ControllerBetter Water, LLC20160—
+1K151637UPT Series Medical RO Water SystemSpecialty Water Technologies20151—
+1K051620Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd SeriesBetter Water, Inc.20053—