FDA.report

510(k) K242320

Device
BD Vacutainer® One Use Holder
Applicant
Becton, Dickinson and Company
510(k) number
K242320
Product code
JKA
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-01
Date received
2024-08-05
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

Related Records

Applicant Contact

Contact
Sravan Rajamani
Address
1 Becton Dr. Franklin Lakes NJ US 07417 07417

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JKA

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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
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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
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
K231282LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC2024-01-26