510(k) Report

Devices descending from K051899

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162516BD Pen NeedleBecton, Dickinson and Company2016102
+1K131358BD Pen NeedleBecton, Dickinson & CO201311—
+1K131125Clickfine Pen NeedleYpsomed AG20131—
+1K123300BD Pen NeedleBecton, Dickinson & CO201320—
+1K121632Comfort EZSimple Diagnostics, Inc.20121—
+1K120690Insulin Pen NeedleTiger Medical Products, Ltd.201220—
+1K112789Easy TouchMhc Medical Products, LLC201102
+1K110105BD Pen NeedleBecton, Dickinson and Company (BD)20110—
+1K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc.20104—
+1K100005BD Pen NeedleBecton, Dickinson and Co.201059—
+1K090111Flexpen NeedleNovo Nordisk, Inc.201016—
+1K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd.200711—
+1K062500Flexpen NeedleNovo Nordisk, Inc.200617—
+1K060007BD Autoshield Pen NeedleBecton, Dickinson & CO2006181
+2K213478BD Pen NeedleBecton, Dickinson and Company202201
+2K213407UltiCare Disposable Pen NeedlesUltimed Incorporated20211—
+2K182320BD Contoured Base Pen NeedleBecton, Dickinson and Company20182—
+2K163578EasyTouch Safety Pen NeedleMhc Medical Products, LLC20184—
+2K171982Droplet Pen NeedleHtl-Strefa S.A20183—
+2K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)Novo Nordisk, Inc.20181—
+2K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc.20160—
+2K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+2K161553BD SafeAssistBecton, Dickinson and Company20160—
+2K143437Droplet Pen NeedlesHtl-Strefa S.A20154—
+2K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG20150—
+2K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+2K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc.20142—
+2K133058Insulin Pen NeedleWenzhou Wuzhou Import & Export Co., Ltd.20140—
+2K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd.201418—
+2K133100Carefine Pen NeedleFacet Technologies20143—
+2K131123Clickfine Autoprotect Pen NeedleYpsomed AG20138—
+2K120191Push-on Needle 30GX8MMScandinavian Health Limited20120—
+2K113186Sterile Insulin Pen NeedleShina Corp.20124—
+2K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd.201221—
+2K110703BD Autoshield Duo Pen NeedleBecton, Dickinson and Company20112—
+2K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+3K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.20260—
+3K250700Pen Injector Needle 32.5Terumo Corporation20250—
+3K230635Pen NeedleJiangsu Caina Medical Co.,Ltd20230—
+3K223286BD AutoShield Duo™ Pen NeedleBecton, Dickinson and Company20221—
+3K220129Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20223—
+3K220614MEDOJECT fine Pen NeedlesChirana T. Injecta20220—
+3K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+3K213156BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company20210—
+3K212015BD Nano 2nd Gen Pen NeedleBecton, Dickinson and Company202102
+3K210258NovoFineNovo Nordisk, Inc.20210—
+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—
+3K181069Disposable Insulin Pen NeedleZhejiang Kindly Medical Devices Co., Ltd.20183—
+3K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20179—
+3K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.20160—
+3K152877SureFine Pen NeedleShina Med Corporation20161—
+3K152824Medt Pen NeedleShandong Caremed Medical Products Co., Ltd.20162—
+3K152514Clickfine AutoProtect Pen NeedleYpsomed AG20157—
+3K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+3K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+4K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD20260—
+4K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20260—
+4K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+4K252886Pen NeedleHh Global Technology, Inc.20261—
+4K250658SureFine Pen NeedleShina Med Corporation20250—
+4K242632Verifine® Pen NeedlesPromisemed Hangzhou Meditech Co., Ltd.20240—
+4K231255NovoFine® PlusNovo Nordisk, Inc.20230—
+4K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+4K221176Insulin Pen NeedleTianjin Huahong Technology Co., Ltd.20220—
+4K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc.20221—
+4K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)Tianjin Huahong Technology Co., Ltd.20211—
+4K210059Promisemed Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20211—
+4K210065Verifine Safety Type Insulin Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20210—
+4K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.20211—
+4K202681Promisemed Covered Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+4K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+4K191853Dual-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20191—
+4K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd.20194—
+4K170846Disposable Insulin Pen NeedleJiangsu Caina Technology Co., Ltd.20171—
+4K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+5K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…Hh Global Technology, Inc.20260—
+5K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…Sandstone Medical (Suzhou), Inc.20260—
+5K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd.20260—
+5K230043Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+5K222739Disposable Insulin Pen NeedleHantech Medical Device Co., Ltd.20230—
+5K221178Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd.20220—
+5K213183Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.20220—
+5K212514Safety Pen Needle for Single Use, Insulin Pen NeedlesBerpu Medical Technology Co., Ltd.20220—
+5K202682Promisemed Triple Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.20200—
+5K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd20201—