FDA.reportPublic FDA data

510(k) K232308

Device
Monarch Blood Collection Set
Applicant
The Monarch Company
510(k) number
K232308
Product code
JKA
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-04
Date received
2023-08-02
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
Jonathan Trawick
Address
4000 Eagle Pt. Corporate Dr. Birmingham AL US 35242 35242

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