510(k) Report

Devices descending from K980987

113 later devices reach Becton Dickinson Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251350BD Plastipak™ SyringeBecton, Dickinson and Company20250—
+1K220184Pump Alignment SyringeJiangsu Caina Medical Co.,Ltd20220—
+1K192538BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson and Company20200—
+1K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+1K182589BD Plastipak SyringeBecton, Dickinson and Company20191—
+1K172670BD Single Use, Hypodermic SyringeBecton, Dickinson and Company20180—
+1K151766BD Single Use, Hypodermic SyringeBecton, Dickinson and Company20152—
+1K131641Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)Nipro Medical Corporation201301
+1K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc.20125—
+1K113241BD Emerald Single Use, Hypodermic SyringeBecton Dickinson20112—
+1K112434BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical201133—
+1K110697Tiger Syringes and NeedlesTiger Medical Products, Ltd.20110—
+1K110771BD Single Use, Hypodermic SyringeBecton, Dickinson and Company20111710
+1K090929Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for…Shanghai Double Dove Industrial Co., Ltd.20091—
+1K07026450 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LBTerumo Europe N.V.200735—
+1K042500Duopross SyringesDuopross Meditech Corporation20054—
+1K042487Procedur SF Safety Syringe DeviceAvanca Medical Devices, Inc.20050—
+1K042486Procedur 10 Syringe DeviceAvanca Medical Devices, Inc.20051—
+2K230235Medline Luer Lock SyringesMedline Industries, LP20240—
+2K210914Sterile Syringe for Single UseJiangsu Suyun Medical Material Co., Ltd.20210—
+2K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…Smiths Medical Asd, Inc.201802
+2K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd.20171—
+2K171362Merit SyringeMerit Medical Systems, Inc.20171—
+2K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.20171Class I
+2K162057ConceptoMed Luer-Jack Slip 10mlConceptomed AS20171—
+2K153553SiO2 Coated syringe 3 mlSio2 Medical Products20160—
+2K142128Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien201531—
+2K143757ANUTRA Feedback Aspiration SyringeAnutra Medical, Inc.20152—
+2K131183Med-RX Oral/Enteral SyringeBenlan, Inc.20140—
+2K132011Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl20140—
+2K132553U&U Sterile Piston Syringe Without NeedleU&U Medical Technology Co, Ltd.201421
+2K130230Sterile Piston Hypodermic Syringes (with/Without Needle), Hypodermic NeedlesWuxi Yushou Medical Applicances Co., Ltd.20130—
+2K130212Safety Hypodermic Needles with/Without SyringeWuxi Yushou Medical Applicances Co., Ltd.20130—
+2K121283BD Emerald Saf-T Single Use, HypodermicBecton, Dickinson and Company20120—
+2K083514Terumo Syringe with/Without NeedleTerumo Europe N.V.200934—
+2K060211Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd.20063—
+2K052075Procedur-10Avanca Medical Devices, Inc.20050—
+3K231877NavaClick Injection SystemLineage Biomedical, Inc.202301
+3K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited20230—
+3K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K211649PCEA Syringe SetBaxter Healthcare Corporation20210—
+3K210103Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited20210—
+3K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.20200—
+3K201816ArthrotapAccuro Technologies, Inc.20201—
+3K191642TK Sterile Piston Syringe without NeedleAnhui Tiankang Medical Technology Co., Ltd.20201—
+3K171805Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 mlConceptomed AS20170—
+3K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd.201732—
+3K160642Medline ENFit SyringeMedline Industries, Inc.20161—
+3K161045MonojectCovidien20163—
+3K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien20164—
+3K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc.201530—
+3K110112Cell-Tissue Converter (CTC) Syringe with NeedleRongshan LI20110—
+4K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…CMT Health PTE., Ltd.20260—
+4K2507333DOSE 1ml SyringeBimed Teknik Aletler Sanayi & Ticaret A.S.20250—
+4K231900A-TAP (previously called Arthrotap)Elcam Medical Acal20230—
+4K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20223—
+4K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd.20221—
+4K202285Medline ENfit OTC Feeding SyringeMedline Industries, Inc.20200—
+4K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd202014—
+4K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd20207—
+4K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use…Gemtier Medical (Shanghai), Inc.20201—
+4K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe…Jiangsu Micsafe Medical Technology Co., Ltd.20190—
+4K171857AMSure® Enteral Feeding Syringe with ENFit TipAmsino International, Inc.20180—
+4K170371DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3…Intervene Group Limited20170—
+4K163586Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science20172—
+4K161963Monoject Enteral Syringe with ENFit ConnectorCovidien20162—
+4K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc.201621—
+5K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+5K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…Sol-Millennium Medical, Inc.20242—
+5K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+5K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc.20220—
+5K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+5K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+5K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+5K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd.20220—
+5K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…Anhui Tiankang Medical Technology Co., Ltd.20220—
+5K212652Sterile Syringe with Fixed Safety Needle for Single UseGemtier Medical (Shanghai), Inc.20220—
+5K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20213—
+5K211753Sterile Syringe With Safety NeedleJiangxi Hongda Medical Equipment Group, Ltd.20210—
+5K210971EnteraLoc FlowVonco Products20211—
+5K211025Oral/Enteral Syringe with ENFit connectorNingbo Tianyi Medical Appliance Co., Ltd.20212—
+5K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+5K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)Jiangsu Shenli Medical Production Co., Ltd.20200—
+5K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd20190Class I
+5K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc.20195—
+5K182649Enteral Feeding Syringes with Enfit ConnectorsJiangsu Kangbao Medical Equipment Co., Ltd.20181—
+5K181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)Jiangsu Micsafe Medical Technology Co., Ltd.20180—
+5K161979ENFit enteral syringeJiangyin Caina Technology Co., Ltd.20173—
+5K161811Medela Low Dose Enteral SyringeMedela, Inc.201701
+5K160855U&U Enteral SyringeU&U Medical Technology Co, Ltd.20160—
+5K162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low…Vr Medical Technology20160—
+6K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.20260—
+6K252483Enteral Syringe (20ml, 60ml)Chirana T.Injecta,A.S.20260—
+6K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+6K250127TSK SyringeTsk Laboratory, Japan20250—
+6K251585Profoject™ Enteral Feeding SyringeCMT Health PTE., Ltd.20250—
+6K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+6K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…Perfect Medical Industry (Vn) Co., Ltd.20241—
+6K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd20241—
+6K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—