510(k) Report

Devices descending from K970259

48 later devices reach E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…Bd Becton Dickinson Vacutainer Systems Preanalytic1998471
+2K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood…Becton, Dickinson and Company20260—
+2K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd20240—
+2K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc.20171—
+2K162233Kurin Blood Culture Collection SetPathway, LLC20162—
+2K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160—
+2K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.20101—
+2K102890K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and…Kawasumi Laboratories America, Inc.20100—
+2K033350BD Vacutainer Safety-Lok Administration Set with FilterBecton, Dickinson & CO20035—
+2K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions2003175
+2K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014—
+2K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO2001237
+2K992145Ecomed Scalp Vein SetGreiner Meditech, Inc.199901
+3K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.20260—
+3K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood…Becton, Dickinson and Company20231—
+3K220799K-SHIELD ZenSb-Kawasumi Laboratories, Inc.20221—
+3K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc.202052
+3K191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle…Kurin, Inc.20200—
+3K181895Kurin PIV Blood Collection Set with High PressureKurin, Inc.20190—
+3K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.20180—
+3K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20166—
+3K122355Vanishpoint Blood Collection SetRetractable Technologies, Inc.20130—
+3K112512Vanishpoint Blood Collection SetRetractable Technologies, Inc.20111—
+3K102010Vacuette Premium Safety Blood Collection SetMedpro Safety Products, Inc.20101—
+3K070547Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)Terumo Europe N.V.20074—
+3K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd.20033—
+3K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO200218—
+4K243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company20250—
+4K231282LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC20240—
+4K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc.20230—
+4K222834Safety Push Button Blood Collection SetJiangsu Caina Medical Co.,Ltd20230—
+4K201237Velano Vascular Blood Collection AdapterVelano Vascular20220—
+4K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc.20222—
+4K212724BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company20221—
+4K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc.20202—
+4K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…Jiangsu Kangbao Medical Equipment Co., Ltd.20200—
+4K181508U&U Blood Collection SetsU&U Medical Technology Co, Ltd.20190—
+4K151991Safelock Disposable Blood Collection Set, Disposable Blood Collection SetJiangyin Caina Technology Co., Ltd.20150—
+4K140175Intravascular Administration SetDelta Med Spa20140—
+4K133894Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V.201401
+4K100946Intravscular Administration SetTerumo Europe N.V.20102—
+4K043328Microflo-Safe Scalp Vein SetDks Loversan Industria Biomedica Spa20050—
+5K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc.20250—
+5K232308Monarch Blood Collection SetThe Monarch Company20230—
+5K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd.20230—
+5K220677Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc.20230—
+5K222299Steripath Micro Blood Collection SystemMagnolia Medical Technologies20220—
+5K133867Surflo Winged Infusion Set with Needle Protection (Surshield)Terumo Europe N.V.20140—