510(k) Report

Devices descending from K131358

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162516BD Pen NeedleBecton, Dickinson and Company2016102
+2K213478BD Pen NeedleBecton, Dickinson and Company202201
+2K213407UltiCare Disposable Pen NeedlesUltimed Incorporated20211—
+2K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company20182—
+2K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+3K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+3K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+3K220614MEDOJECT fine Pen NeedlesChirana T. Injecta20220—
+3K213156BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company20210—
+3K212015BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company202102
+3K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd.20200—