510(k) Report

Devices descending from K931367

147 later devices reach Vacutainer Brand Luer Adapter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20021003
+1K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO2001237
+1K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…Becton Dickinson Vacutainer Systems1999144
+1K983490Terumo Venoject,Luer AdapterTerumo Corp.199821—
+2K240355FROG (Filter Removal of Glass)Carrtech Corp20250—
+2K243649BD Vacutainer® Multiple Sample Luer AdapterBecton, Dickinson and Company20250—
+2K220799K-SHIELD ZenSb-Kawasumi Laboratories, Inc.20221—
+2K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd20206—
+2K181743Blood Transfer Accessory (BTA)Nsp Tech Pte, Ltd.20190—
+2K181754Blood Collection Accessory (BUCA)Nsp Tech Pte, Ltd.20190—
+2K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc.20191—
+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—
+2K160532Greiner HoldexGreiner Bio-One Na, Inc.20161—
+2K133635Easypoint NeedleRetractable Technologies, Inc.201401
+2K102010Vacuette Premium Safety Blood Collection SetMedpro Safety Products, Inc.20101—
+2K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+2K072247Sterican Hypodermic NeedlesB.Braun Medical, Inc.20071—
+2K070440BD Hypoint NeedleBecton, Dickinson & CO200791—
+2K041358Venoject Luer AdapterTerumo Europe N.V.20040—
+2K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO200218—
+2K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014—
+3K253047Pressone™Nipro Medical Corporation20260—
+3K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.20240—
+3K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc.20230—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+3K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+3K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company20231—
+3K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Sb-Kawasumi Laboratories, Inc.20230—
+3K213690Eclipse Blood Collection SetEclipse Medcorp, LLC20220—
+3K222141Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K181508U&U Blood Collection SetsU&U Medical Technology Co, Ltd.20190—
+3K180545VACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc.201801
+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—
+3K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd.20033—
+3K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions2003175
+4K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.20260—
+4K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+4K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood…Becton, Dickinson and Company20231—
+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—
+4K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…Jiangsu Kangbao Medical Equipment Co., Ltd.20200—
+4K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc.202052
+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—
+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—
+4K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20166—
+4K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection SetJiangyin Caina Technology Co., Ltd.20150—
+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—
+4K122355Vanishpoint Blood Collection SetRetractable Technologies, Inc.20130—
+4K112512Vanishpoint Blood Collection SetRetractable Technologies, Inc.20111—
+4K110853VR Medical Enteral Oral SyringeVr Medical20110—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.201136—
+4K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa20050—
+5K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.20250—
+5K243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company20250—
+5K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…Berpu Medical Technology Co., Ltd.20240—
+5K231282LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC20240—
+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—
+5K222834Safety Push Button Blood Collection SetJiangsu Caina Medical Co.,Ltd20230—
+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—
+5K201237Velano Vascular Blood Collection AdapterVelano Vascular20220—
+5K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc.20222—
+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—
+5K212724BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20221—
+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—