510(k) Report

Devices descending from K980414

47 later devices reach Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood…Becton, Dickinson and Company20260—
+1K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd20240—
+1K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc.20171—
+1K162233Kurin Blood Culture Collection SetPathway, LLC20162—
+1K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160—
+1K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.20101—
+1K102890K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and…Kawasumi Laboratories America, Inc.20100—
+1K033350BD Vacutainer Safety-Lok Administration Set with FilterBecton, Dickinson & CO20035—
+1K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions2003175
+1K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014—
+1K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO2001237
+1K992145Ecomed Scalp Vein SetGreiner Meditech, Inc.199901
+2K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.20260—
+2K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood…Becton, Dickinson and Company20231—
+2K220799K-SHIELD ZenSb-Kawasumi Laboratories, Inc.20221—
+2K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc.202052
+2K191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle…Kurin, Inc.20200—
+2K181895Kurin PIV Blood Collection Set with High PressureKurin, Inc.20190—
+2K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.20180—
+2K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20166—
+2K122355Vanishpoint Blood Collection SetRetractable Technologies, Inc.20130—
+2K112512Vanishpoint Blood Collection SetRetractable Technologies, Inc.20111—
+2K102010Vacuette Premium Safety Blood Collection SetMedpro Safety Products, Inc.20101—
+2K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V.20074—
+2K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd.20033—
+2K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO200218—
+3K243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company20250—
+3K231282LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC20240—
+3K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc.20230—
+3K222834Safety Push Button Blood Collection SetJiangsu Caina Medical Co.,Ltd20230—
+3K201237Velano Vascular Blood Collection AdapterVelano Vascular20220—
+3K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc.20222—
+3K212724BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20221—
+3K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc.20202—
+3K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…Jiangsu Kangbao Medical Equipment Co., Ltd.20200—
+3K181508U&U Blood Collection SetsU&U Medical Technology Co, Ltd.20190—
+3K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection SetJiangyin Caina Technology Co., Ltd.20150—
+3K140175Intravascular Administration SetDelta Med Spa20140—
+3K133894Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V.201401
+3K100946Intravscular Administration SetTerumo Europe N.V.20102—
+3K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa20050—
+4K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc.20250—
+4K232308Monarch Blood Collection SetThe Monarch Company20230—
+4K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.20230—
+4K220677Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc.20230—
+4K222299Steripath Micro Blood Collection SystemMagnolia Medical Technologies20220—
+4K133867Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20140—