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
+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—
+6K231723Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+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—
+6K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd.20220—
+6K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd.20220—
+6K213535Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+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—
+6K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+6K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+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—
+7K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+7K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+8K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—
+8K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—