510(k) Report

Devices descending from K102108

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122971Clickfine Pen NeedleP/L Biomedical20122—
+1K110312Clickfine Autoprotect Pen NeedleYpsomed AG20129—
+2K131123Clickfine Autoprotect Pen NeedleYpsomed AG20138—
+2K131125Clickfine Pen NeedleYpsomed AG20131—
+3K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+3K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—
+4K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+4K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+5K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd.20260—
+5K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+5K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+5K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—
+6K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—