Cleared Traditional

K240455 - BD Vacutainer Citrate Blood Collection ...

K240455 is the FDA 510(k) clearance for BD Vacutainer Citrate Blood Collection ... by Becton, Dickinson and Company. It is a Class 2 Hematology device (product code GIM) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

K240455 is an FDA 510(k) clearance for the BD Vacutainer® Citrate Blood Collection Tubes. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on October 31, 2024 after a review of 259 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K240455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 113d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 20
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K240455.
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
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · Sherwood Medical Co. · Dec 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · Sherwood Medical Co. · May 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
K933939 · Organon Teknika Corp. · Feb 1994