Cleared Traditional

K933401 - THE BUCK

K933401 is an FDA 510(k) clearance for THE BUCK, manufactured by Medical Implements, Inc.. The device is a Class 2 Toxicology device with product code JKA cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K933401 · Medical Implements, Inc. · Toxicology device
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Feb 1994
Decision
213d
Days
Class 2
Risk

K933401 is an FDA 510(k) clearance for the THE BUCK. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Medical Implements, Inc. (Richmond, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 213 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Implements, Inc. devices

FDA 510(k) Submission Details - K933401

510(k) Number K933401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date February 10, 1994
Days to Decision 213 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 87d · This submission: 213d
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 Toxicology devices follow this clearance model.

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

All 169
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K933401.
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN
K942240 · 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
MICROTAINER BRAND TUBE WITH EDTA
K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1993
VACUTAINER BRAND LUER ADAPTER
K931367 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993