510(k) Report

Devices descending from K002938

121 later devices reach B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100812Ulticare Disposable Pen NeedlesUltimed, Inc.20109—
+1K070988SC Profi Fine Pen Needle, Models; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)Shinchang Medical Co., Ltd.20070—
+1K052561Terumo Micro Tapered Pen NeedleKofu Factory of Terumo Corp.200517—
+1K050464Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2Ultimed, Inc.20050—
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20021003
+2K240355FROG (Filter Removal of Glass)Carrtech Corp20250—
+2K163437hypodermic Pinpoint™ GT NeedleC.R. Bard, Inc.20170—
+2K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…Becton, Dickinson and Company20161—
+2K140516Terumo Pen Injector Needle 34Kofu Factory of Terumo Corp.20144—
+2K133635Easypoint NeedleRetractable Technologies, Inc.201401
+2K133100Carefine Pen NeedleFacet Technologies20143—
+2K113186Sterile Insulin Pen NeedleShina Corp.20124—
+2K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+2K072247Sterican Hypodermic NeedlesB.Braun Medical, Inc.20071—
+2K070440BD Hypoint NeedleBecton, Dickinson & CO200791—
+2K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd.200711—
+3K253047Pressone™Nipro Medical Corporation20260—
+3K250700Pen Injector Needle 32.5Terumo Corporation20250—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+3K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd.20221—
+3K192082Droplet Pen Needle 34GHtl-Strefa S.A20202—
+3K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc.20160—
+3K152877SureFine Pen NeedleShina Med Corporation20161—
+3K141749Carefine Pen Needle Family Including Quintapoint and SuperpointFacet Technologies, LLC20140—
+3K140568Carefine Pen Needle with Quintapoint and SuperpointFacet Technologies, LLC20141—
+3K130230Sterile Piston Hypodermic Syringes (with/Without Needle), Hypodermic NeedlesWuxi Yushou Medical Applicances Co., Ltd.20130—
+3K132552U&U Sterile Hypodermic NeedleU&U Medical Technology Co, Ltd.20136—
+3K131040Extavipro Sterican 30GB.Braun Melsungen AG20130—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,201131—
+3K110697Tiger Syringes and NeedlesTiger Medical Products, Ltd.20110—
+3K092831Disposable Hypodermic NeedleFeel Tech20100—
+3K090929Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for…Shanghai Double Dove Industrial Co., Ltd.20091—
+3K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.200878—
+4K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.20260—
+4K250658SureFine Pen NeedleShina Med Corporation20250—
+4K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+4K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needlePikdare Spa20230—
+4K211211Sterile syringes for single use with/without needleAzur Medical Company, Inc.20211—
+4K210227Sterile syringe for single use with/without needleZhejiang Kangkang Medical-Devices Co., Ltd.20212—
+4K210991Disposable Sterile Syringe, Disposable Sterile Syringe with NeedleGuangdong Antmed Co., Ltd.20210—
+4K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A20200—
+4K191643TK Sterile Hypodermic NeedleAnhui Tiankang Medical Technology Co., Ltd.20190—
+4K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd.201913—
+4K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd.201812—
+4K172938Disposable Sterile NeedleJiangsu Caina Medical Co.,Ltd20180—
+4K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC20170—
+4K163161Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd.20179—
+4K163162Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group, Ltd.20170—
+4K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC20174—
+4K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.20165—
+4K153537Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc.20165—
+4K151949Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd.20156—
+4K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd.20154—
+4K124037Jung Rim Single Use Hypodermic Syringe with NeedleJung Rim Medical Industrial Co., Ltd.20130—
+4K110853VR Medical Enteral Oral SyringeVr Medical20110—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.201136—
+5K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.20250—
+5K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…Berpu Medical Technology Co., Ltd.20240—
+5K233037Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd.20230—
+5K221777Disposable Sterile SyringeWeihai Shengjie Medical Technology Co., Ltd.20230—
+5K231720Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+5K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc.20230—
+5K212207Sterile Hypodermic Syringe for Single UseShandong Weigao Group Medical Polymer Co., Ltd.20230—
+5K223453Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20232—
+5K212635SofjecHwajin Medical Co., Ltd.20232—
+5K203211Insulin syringe with integrated needle DLDlp Medical Products, Corp.20230—
+5K221045Insulin Syringes without needleBerpu Medical Technology Co., Ltd.20220—
+5K221079Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd.20221—
+5K221066Sterile Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+5K221080Sterile Safety Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+5K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic…Jiangsu Jichun Medical Devices Co., Ltd.20220—
+5K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin…Shandong Zhushi Pharmaceutical Group Co., Ltd.20220—
+5K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd.20221—
+5K211482Disposable Syringe with NeedleShandong Qinkai Medical Industry Co., Ltd.20220—
+5K201044CHIRANA Insulin SyringesChirana T. Injecta20221—
+5K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc.20214—
+5K211728Sterile hypodermic syringes for single useJiangsu Kangyou Medical Instrument Co., Ltd.20210—
+5K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd.20210—
+5K210232Sterile Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20210—
+5K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd.20213—
+5K201930Nanum SyringeNanum Company Co., Ltd.20210—
+5K193273Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20212—
+5K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile…Set Medikal Sanayi VE Ticaret Anonim Sirketi20202—
+5K191644TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.20203—
+5K200242StaClear SyringeTribofilm Research, Inc.20205—
+5K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation20190—
+5K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd20180—
+5K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC20171—
+5K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+5K113673Mysafety SyringeMedicalchain Internartional Corporation20120—
+6K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.20260—
+6K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.20260—
+6K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd.20250—
+6K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…Hangzhou Sightnovo Medical Technology Co., Ltd.20250—
+6K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20251—
+6K242434Insulin SyringesChirana T. Injecta20240—
+6K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+6K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC20240—
+6K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc.20240—
+6K233794Insulin SyringeSpm Medicare Pvt., Ltd.20240—