JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection Class II

FDA Device Classification

Classification Details

Product Code
JKA
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252040becton, dickinson andBD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin BlooMarch 13, 2026
K251812magnolia medical technologiesSteripath® Flow™ Blood Collection SystemSeptember 25, 2025
K243207becton, dickinson andBD Vacutainer® Eclipse™ Blood Collection NeedleJuly 3, 2025
K250961promisemed hangzhou meditech coBlood collection tube holdersJune 4, 2025
K244047venocareNavi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)May 23, 2025
K250907sol-millennium medicalSol-Guard TM XtraThin Safety Pull-Button Blood Collection SetApril 30, 2025
K243649becton, dickinson andBD Vacutainer® Multiple Sample Luer AdapterMarch 21, 2025
K241586becton dickinson infusion therapy systemsPIVO™ Pro Needle-free Blood Collection DeviceFebruary 27, 2025
K242320becton, dickinson andBD Vacutainer® One Use HolderNovember 1, 2024
K233979greiner bio-one north americaVACUETTE® QUICKSHIELD Complete (Plus)July 19, 2024
K232781jiangsu caina medical coSafety Sliding Blood Collection SetMarch 7, 2024
K231373becton, dickinson andBD Vacutainer® K2 EDTA Blood Collection TubesFebruary 2, 2024
K231282lifeoutcomesLifeOutcomes C-Quest™ Blood Culture Sampling DeviceJanuary 26, 2024
K231237becton, dickinson andBD Vacutainer® Fluoride Blood Collection TubesJanuary 19, 2024
K232881jiangsu kangbao medical equipment coWinged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood ColDecember 22, 2023
K230855becton, dickinson andBD Vacutainer® Serum Separator (SST™) Blood Collection TubesDecember 20, 2023
K232308monarchMonarch Blood Collection SetDecember 4, 2023
K230391becton, dickinson andBD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary December 1, 2023
K213146jiangsu rongye technology coSafety butterfly type blood collection needle, Butterfly type blood collection nOctober 27, 2023
K220458innovative medical technologiesUltraFlo-R Push Button Blood Collection SetSeptember 29, 2023