510(k) Report

Devices descending from K100005

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143437Droplet Pen NeedlesHtl-Strefa S.A20154—
+1K133100Carefine Pen NeedleFacet Technologies20143—
+1K131358BD Pen NeedleBecton, Dickinson & CO201311—
+1K131125Clickfine Pen NeedleYpsomed AG20131—
+1K123300BD Pen NeedleBecton, Dickinson & CO201320—
+1K121632Comfort EZSimple Diagnostics, Inc.20121—
+1K113186Sterile Insulin Pen NeedleShina Corp.20124—
+1K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd.201221—
+1K112789Easy TouchMhc Medical Products, LLC201102
+1K110105BD Pen NeedleBecton, Dickinson and Company (BD)20110—
+2K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+2K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+2K162516BD Pen NeedleBecton, Dickinson and Company2016102
+2K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.20160—
+2K152877SureFine Pen NeedleShina Med Corporation20161—
+2K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—
+2K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+2K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+2K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+2K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+2K120690Insulin Pen NeedleTiger Medical Products, Ltd.201220—
+3K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+3K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+3K250700Pen Injector Needle 32.5Terumo Corporation20250—
+3K250658SureFine Pen NeedleShina Med Corporation20250—
+3K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+3K213478BD Pen NeedleBecton, Dickinson and Company202201
+3K213407UltiCare Disposable Pen NeedlesUltimed Incorporated20211—
+3K202005NovoFine Plus 32G Tip x 4 mmNovo Nordisk, Inc.20201—
+3K192464Injection Pen NeedleGangan Medical Technology Jiangsu Co., Ltd.20200—
+3K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+3K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company20182—
+3K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+3K133058Insulin Pen NeedleWenzhou Wuzhou Import & Export Co., Ltd.20140—
+3K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd.201418—
+4K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+4K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+4K220614MEDOJECT fine Pen NeedlesChirana T. Injecta20220—
+4K213156BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company20210—
+4K212015BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company202102
+4K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+4K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd.20183—
+4K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+4K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.20160—
+4K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd.20162—
+5K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+5K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.20220—
+5K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd.20211—
+5K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+5K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+5K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+5K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+5K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+5K170846Disposable Insulin Pen NeedleJiangsu Caina Technology Co., Ltd.20171—
+6K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+6K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+6K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+6K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—
+6K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—