510(k) Report

Devices descending from K163578

4 later devices reach EasyTouch Safety Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220129Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20223—
+2K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20260—
+2K252886Pen NeedleHh Global Technology, Inc.20261—
+3K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…Hh Global Technology, Inc.20260—