510(k) Report

Devices descending from K181447

4 later devices reach Safety insulin needle for single use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+1K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+1K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—
+2K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—