510(k) Report

Devices descending from K971278

2 later devices reach Pure Company Fluid Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990479Hygeniclear WKR 1, Water-Delivery Device UltraclearHygenitek, Inc.19990—
+1K981171Eradic-AllTheratechnologies, Inc.19980—