Cleared Traditional

K252344 - BD Vacutainer® Serum Blood Collection Tubes

Also marketed or referenced as:
BD Vacutainer® Rapid Serum Tubes (RST)

K252344 is an FDA 510(k) clearance for BD Vacutainer Serum Blood Collection Tubes, manufactured by Becton, Dickinson and Company. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K252344 · Becton, Dickinson and Company · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
445d
Days
Class 2
Risk

K252344 is an FDA 510(k) clearance for the BD Vacutainer® Serum Blood Collection Tubes. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry submissions.

FDA 510(k) Submission Details - K252344

510(k) Number K252344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2025
Decision Date October 16, 2026
Days to Decision 445 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 89d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 237
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K252344.
Profoject™ Safe Push Button Blood Collection Sets
K262242 · CMT Health PTE., Ltd. · Oct 2026
Sol-Guard™ Safety Pull Button Collection Set
K260857 · Sol-Millennium Medical, Inc. · Oct 2026
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K262215 · CMT Health PTE., Ltd. · Sep 2026
Female Culture Device
K252899 · Zhejiang Kindly Medical Device Co., Ltd. · Jun 2026
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · Becton, Dickinson and Company · Apr 2026
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube
K252378 · Becton, Dickinson and Company · Apr 2026
K252344 · BD Vacutainer® Serum Blood Collection Tubes
Download PDF FDA Summary Becton, Dickinson and…