Cleared Traditional

K213670 - BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213670 · Becton, Dickinson and Company · Hematology device
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Aug 2023
Decision
641d
Days
Class 2
Risk

K213670 is an FDA 510(k) clearance for the BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Colle.... 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 August 25, 2023 after a review of 641 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

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Submission Details

510(k) Number K213670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date August 25, 2023
Days to Decision 641 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
528d slower than avg
Panel avg: 113d · This submission: 641d
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.