Cleared Traditional

K002456 - MICROTAINER BRAND SODIUM FLUORIDE/EDTA ...

K002456 is the FDA 510(k) clearance for MICROTAINER BRAND SODIUM FLUORIDE/EDTA ... by Becton Dickinson Vacutainer Systems. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K002456 · Becton Dickinson Vacutainer Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
84d
Days
Class 2
Risk

K002456 is an FDA 510(k) clearance for the MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton Dickinson Vacutainer Systems (Franklin Lake, US). The FDA issued a Cleared decision on November 2, 2000 after a review of 84 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 Becton Dickinson Vacutainer Systems devices

Submission Details

510(k) Number K002456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date November 02, 2000
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K002456.
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538
K022426 · Becton, Dickinson & CO · Aug 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO · Jul 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · Becton, Dickinson & CO · Feb 2002
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · Ohmeda Medical · Jan 1998