Cleared Traditional

K942240 - DUPONT APC BLOOD COLLECTION CONTAINER W...

K942240 is an FDA 510(k) clearance for DUPONT APC BLOOD COLLECTION CONTAINER W..., manufactured by Dupont Medical Products. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K942240 · Dupont Medical Products · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
100d
Days
Class 2
Risk

K942240 is an FDA 510(k) clearance for the DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 100 days - within the typical 510(k) review window.

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 Dupont Medical Products devices

FDA 510(k) Submission Details - K942240

510(k) Number K942240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date August 17, 1994
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 119
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K942240.
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
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
MICROTAINER BRAND TUBE WITH EDTA(K2)
K940905 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · International Technidyne Corp. · May 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · International Technidyne Corp. · Jan 1994