Cleared Traditional

K013971 - BD VACUTAINER SAFETY COAGULATION TUBE

K013971 is an FDA 510(k) clearance for BD VACUTAINER SAFETY COAGULATION TUBE, manufactured by Becton, Dickinson & CO. The device is a Class 2 Hematology device with product code JKA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K013971 · Becton, Dickinson & CO · Hematology device
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Feb 2002
Decision
60d
Days
Class 2
Risk

K013971 is an FDA 510(k) clearance for the BD VACUTAINER SAFETY COAGULATION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K013971

510(k) Number K013971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date February 01, 2002
Days to Decision 60 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
53d faster than avg
Panel avg: 113d · This submission: 60d
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 Hematology devices follow this clearance model.

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

All 180
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K013971.
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO · Jul 2002
SAMPLOK LUER KIT
K021941 · Itl Corporation Pty, Ltd. · Jul 2002
SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K012221 · Biosafe Laboratories, Inc. · Apr 2002
VACUETTE EVACUATED BLOOD COLLECTION TUBES
K011699 · Greiner Bio-One Vacuette North America · Jun 2001
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
K002456 · Becton Dickinson Vacutainer Systems · Nov 2000
VACUETTE WITH PPACK
K002777 · Greiner Vacuette North America, Inc. · Oct 2000