510(k) Report

Devices descending from K123300

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+1K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+1K131358BD Pen NeedleBecton, Dickinson & CO201311—
+2K250700Pen Injector Needle 32.5Terumo Corporation20250—
+2K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc.20201—
+2K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+2K162516BD Pen NeedleBecton, Dickinson and Company2016102
+3K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+3K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+3K213478BD Pen NeedleBecton, Dickinson and Company202201
+3K213407UltiCare Disposable Pen NeedlesUltimed Incorporated20211—
+3K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+3K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company20182—
+3K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+4K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+4K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+4K220614MEDOJECT fine Pen NeedlesChirana T. Injecta20220—
+4K213156BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company20210—
+4K212015BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company202102
+4K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd.20200—