510(k) Report

Devices descending from K060007

18 later devices reach BD Autoshield Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163578EasyTouch Safety Pen NeedleMhc Medical Products, LLC20184—
+1K161553BD SafeAssistBecton, Dickinson and Company20160—
+1K131123Clickfine Autoprotect Pen NeedleYpsomed AG20138—
+1K110703BD Autoshield Duo Pen NeedleBecton, Dickinson and Company20112—
+2K223286BD AutoShield Duo™ Pen NeedleBecton, Dickinson and Company20221—
+2K220129Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20223—
+2K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+3K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD20260—
+3K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20260—
+3K252886Pen NeedleHh Global Technology, Inc.20261—
+3K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+3K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+4K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…Hh Global Technology, Inc.20260—
+4K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd.20260—
+4K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+4K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+4K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—
+5K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—