510(k) Report

Devices descending from K994197

17 later devices reach Disentronic Penfine Injection Pen Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102108Clickfine Pen NeedleYpsomed AG201013—
+1K013782Disetronic Penfine Insulin Injection Pen NeedleDisetronic Medical Systems20014—
+2K122971Clickfine Pen NeedleP/L Biomedical20122—
+2K110312Clickfine Autoprotect Pen NeedleYpsomed AG20129—
+2K100436Clickfine Pen NeedleYpsomed AG20103—
+3K131123Clickfine Autoprotect Pen NeedleYpsomed AG20138—
+3K131125Clickfine Pen NeedleYpsomed AG20131—
+3K122969Clickfine Pen NeedleP/L Biomedical20122—
+4K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+4K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—
+5K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+5K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+6K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd.20260—
+6K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+6K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+6K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—
+7K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—