Cleared Traditional

BD Vacutainer? Citrate Blood Collection Tubes

K240455 · Becton, Dickinson and Company · Hematology
Oct 2024
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K240455 is an FDA 510(k) clearance for the BD Vacutainer? Citrate Blood Collection Tubes, a Tubes, Vacuum Sample, With Anticoagulant (Class II — Special Controls, product code GIM), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on October 31, 2024, 259 days after receiving the submission on February 15, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K240455 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2024
Decision Date October 31, 2024
Days to Decision 259 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIM — Tubes, Vacuum Sample, With Anticoagulant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

Similar Devices — GIM Tubes, Vacuum Sample, With Anticoagulant

All 38
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
K230493 · Becton, Dickinson and Company · Nov 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · Caltag Medsystems, Ltd. · Jun 2017
CYTO-CHEX BCT
K080552 · Streck · Jul 2008
DS30 HCY BLOOD COLLECTION TUBES
K012152 · Drew Scientific , Ltd. · Sep 2001
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · Becton Dickinson Vacutainer Systems · Jun 1997

More from Becton, Dickinson and Company

View all
BD Vacutainer? Plasma Separator Tubes (PST?), BD Vacutainer? Sodium Heparin Blood Collection Tubes
K252040 · JKA · Mar 2026
0.9 % Sodium Chloride Injection, USP, BD PosiFlush? SP Syringe
K250884 · NGT · Dec 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
K250358 · PCI · Oct 2025
BD PhaSeal? Optima Connecting Set (C83-O); BD PhaSeal? Optima Spike Set (C180-O)
K250059 · ONB · Sep 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 ?g/mL)
K251713 · LON · Aug 2025