Cleared Traditional

K940905 - MICROTAINER BRAND TUBE WITH EDTA(K2)

K940905 is an FDA 510(k) clearance for MICROTAINER BRAND TUBE WITH EDTA(K2), 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 159-day FDA review.

K940905 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
159d
Days
Class 2
Risk

K940905 is an FDA 510(k) clearance for the MICROTAINER BRAND TUBE WITH EDTA(K2). 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 August 2, 1994 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K940905

510(k) Number K940905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date August 02, 1994
Days to Decision 159 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
71d slower than avg
Panel avg: 88d · This submission: 159d
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 K940905.
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
K944566 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN
K942241 · Dupont Medical Products · Aug 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN
K942240 · Dupont Medical Products · Aug 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · International Technidyne Corp. · May 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · International Technidyne Corp. · Jan 1994
MICROTAINER BRAND TUBE WITH EDTA
K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1993