Cleared Traditional

K965202 - VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET

K965202 is an FDA 510(k) clearance for VACUTAINER BRAND SAFETY-LOK BLOOD COLLE..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
46d
Days
Class 2
Risk

K965202 is an FDA 510(k) clearance for the VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 46 days - a notably fast clearance cycle.

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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K965202

510(k) Number K965202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1996
Decision Date February 10, 1997
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 171
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K965202.
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · Greiner America, Inc. · May 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971239 · Greiner America, Inc. · May 1997
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
K964698 · Andwin Scientific · Mar 1997
PICO MODELS 30, 50, 70
K962158 · Radiometer America, Inc. · Oct 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · Smiths Industries Medical Systems, Inc. · Oct 1996
GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
K960860 · Greiner America, Inc. · Sep 1996