FDA.reportPublic FDA data

510(k) K230080

Device
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
Applicant
Yangzhou Medline Industry, Co., Ltd.
510(k) number
K230080
Product code
JKA
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-07
Date received
2023-01-11
Regulation
862.1675
Classification name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hu Tingting
Address
#108, Jinshan Rd., Economic Development Zone Yangzhou CN 225000 225000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JKA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company2026-04-15
K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company2026-04-10
K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company2026-04-10
K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company2026-03-13
K251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies2025-09-25
K243207BD Vacutainer® Eclipse™ Blood Collection NeedleBecton, Dickinson and Company2025-07-03
K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.2025-06-04
K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc.2025-05-23
K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc.2025-04-30
K243649BD Vacutainer® Multiple Sample Luer AdapterBecton, Dickinson and Company2025-03-21
K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc.2025-02-27
K242320BD Vacutainer® One Use HolderBecton, Dickinson and Company2024-11-01
K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc.2024-07-19
K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd2024-03-07
K231373BD Vacutainer® K2 EDTA Blood Collection TubesBecton, Dickinson and Company2024-02-02