510(k) Report

Devices descending from K980580

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation20190—
+5K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd20180—
+5K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+5K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20159—
+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—
+6K231519Revital CadyRevital Healthcare (Epz) Limited20230—
+6K230372VitreJect SyringeOcuject, LLC20230—
+6K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single UseJiangsu Zhiyu Medical Instrument Co, Ltd.20230—
+6K222672Disposable Insulin SyringeHantech Medical Device Co., Ltd.20230—
+6K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd.20221—
+6K213560Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd.20222—
+6K210712Verifine Mechanical Safety Insulin SyringePromisemed Hangzhou Meditech Co., Ltd.20210—
+6K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+6K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi20210—
+6K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC20211—
+6K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+6K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+6K192866Chemfort CSTDSimplivia Healthcare, Ltd.202031
+6K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20181—
+6K170680TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant20170—
+7K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—
+7K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.20250—
+7K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd.20250—
+7K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd.20250—
+7K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte., Ltd.20240—
+7K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+7K231286Chemfort® Catheter AdaptorSimplivia Healthcare, Ltd.20230—
+7K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+7K210707OnGuard2 Chemfort Closed Administration (CADM)Simplivia Healthcare, Ltd.20210—
+8K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—
+8K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—