510(k) Report

Devices descending from K110312

9 later devices reach Clickfine Autoprotect Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131123Clickfine Autoprotect Pen NeedleYpsomed AG20138—
+2K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+3K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+3K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+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—