510(k) Report

Devices descending from K980580

141 later devices reach Becton Dickinson Syringes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203453BD Hypodermic SyringeBecton, Dickinson and Company20210—
+1K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.20120—
+1K110112Cell-Tissue Converter (CTC) Syringe with NeedleRongshan LI20110—
+1K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+1K062753Forsure Disposable Syringe with Needle, Model 1CC, 3C, 5CC, 10CC, 20CC, 50CCSurgimed, Inc.20070—
+1K050134Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc.20056—
+1K024052Merit Medical 1-ML SyringeMerit Medical Systems, Inc.2003111—
+1K023752BD Integra SyringeBd2003162
+1K991758Monoject Insulin SyringeThe Kendal Co.19993—
+2K220114PowerPAK SyringeVault Paragon Group, Inc.20231—
+2K182274Orbit Subretinal Delivery SystemOrbit Biomedical, Inc.20184—
+2K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+2K132120WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd.20135—
+2K111091Merit Medical 20 ML SyringeMerit Medical Systems, Inc.20114—
+2K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited20100—
+2K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited20082—
+2K070856Icu Medical Single-Use SyringeIcu Medical, Inc.200718—
+2K070936Welmed Hypodermic SyringeWelmed, Inc.200788—
+2K062780Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd.20070—
+2K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.20061—
+2K033373Monoject Insulin SyringeTyco Healthcare200301
+3K250847VaporShieldVault Paragon Group, Inc.20250—
+3K221981SafeR Syringe and SafeR StingRoncadelle Operations Srl20220—
+3K200325Orbit Subretinal Delivery SystemOrbit Biomedical20203—
+3K173601Merit SyringeMerit Medical Systems, Inc.201841
+3K163597VacLok AT Vacuum SyringeMerit Medical Systems, Inc.20171—
+3K163084Merit Coronary Control SyringeMerit Medical Systems, Inc.20171—
+3K152783Merit 20 mL SyringeMerit Medical Systems, Inc.20152—
+3K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd.20153—
+3K142636Merit 10mL SyringeMerit Medical Systems, Inc.20140—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,201131—
+3K103736DMC Medical Single-Use Polycarbonate SyringeDmc Medical, Ltd.20114—
+3K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited20101—
+3K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc.200812Class I
+3K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.200878—
+3K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+4K250853Merit SyringeMerit Medical Systems, Inc.20250—
+4K242143Angiography InjectorShandong Int Medical Instruments Co., Ltd.20240—
+4K233069Removal System Large Bore 60 cc SyringeInari Medical, Inc.20240—
+4K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+4K231727Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd.20230—
+4K223678Sterile Syringes for Single UseShanghai Kindly Enterprise Development Group Co., Ltd.20230—
+4K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+4K203738QitexioMedex20220—
+4K210229Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+4K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc.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—
+4K203264MicroDose InjectorMedone Surgical, Inc.20212—
+4K191254EndoClotEndoclot Plus Co., Ltd.20201—
+4K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd.201913—
+4K182216Merit SyringeMerit Medical Systems, Inc.20180—
+4K182279Merit SyringeMerit Medical Systems, Inc.20180—
+4K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemIcu Medical, Inc.201809
+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—
+4K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC20171—
+4K161812Freedom SyringeProcedure Products, Inc.20170—
+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—
+4K124037Jung Rim Single Use Hypodermic Syringe with NeedleJung Rim Medical Industrial Co., Ltd.20130—
+4K131549Chemolock, Chemolock PortIcu Medical, Inc.201310Class I
+4K110853VR Medical Enteral Oral SyringeVr Medical20110—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.201136—
+5K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd.20260—
+5K250501System SophiThis AG20250—
+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—
+5K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd.20220—
+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—
+5K200242StaClear SyringeTribofilm Research, Inc.20205—