510(k) Report

Devices descending from K972404

127 later devices reach Vacutainer Brand Safety Blood Collection Assembly (Multiple) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20021003
+1K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems1998251
+2K240355FROG (Filter Removal of Glass)Carrtech Corp20250—
+2K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.20230—
+2K200932Blood Collection NeedlesVacutest Kima Srl20210—
+2K202325EasyPoint Blood Collection PlusRetractable Technologies, Inc.20210—
+2K181730BD Vacutainer Eclipse UltraFill Blood Collection NeedleBecton, Dickinson and Company20190—
+2K170824BD Vacutainer Eclipse Signal Blood Collection NeedleBecton, Dickinson and Company20180—
+2K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Zhejiang Kindly Medical Devices Co., Ltd.201813—
+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—
+2K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160—
+2K133635Easypoint NeedleRetractable Technologies, Inc.201401
+2K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+2K072247Sterican Hypodermic NeedlesB.Braun Medical, Inc.20071—
+2K070440BD Hypoint NeedleBecton, Dickinson & CO200791—
+2K033478Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America20035—
+3K253047Pressone™Nipro Medical Corporation20260—
+3K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set…Yangzhou Medline Industry, Co., Ltd.20231—
+3K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleNipro Medical Corporation20230—
+3K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single…Jiangsu Micsafe Medical Technology Co., Ltd.20211—
+3K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd20206—
+3K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care…Sol-Millennium Medical, Inc.20181—
+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—
+3K102774Vacuette Quickshield with Snappy Tude HolderGreiner Bio-One North America, Inc.201021
+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—
+3K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc.200711
+4K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.20250—
+4K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.20240—
+4K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+4K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—
+4K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company20231—
+4K213690Eclipse Blood Collection SetEclipse Medcorp, LLC20220—
+4K222141Safety Blood Collection Needle (Without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+4K220900Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+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—
+4K201009CHIRAVAC Blood Collection NeedlesChirana T. Injecta20210—
+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—
+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—
+4K113505Vacuette Quickshield with Snappy Tube HolderGreiner Bio-One North America, Inc.20121—
+4K110853VR Medical Enteral Oral SyringeVr Medical20110—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.201136—
+5K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.20260—
+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—
+5K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderMyco Medical Supplies, Inc.20180—
+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—