Cleared Traditional

K926253 - SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE

K926253 is an FDA 510(k) clearance for SUDORMED SWEAT PATCH SPECIMEN CONTAINER..., manufactured by Sudormed, Inc.. The device is a Class 2 Toxicology device with product code JKA cleared through the Traditional 510(k) pathway after a 942-day FDA review.

K926253 · Sudormed, Inc. · Toxicology device
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Jul 1995
Decision
942d
Days
Class 2
Risk

K926253 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sudormed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 942 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

FDA 510(k) Submission Details - K926253

510(k) Number K926253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date July 14, 1995
Days to Decision 942 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
855d slower than avg
Panel avg: 87d · This submission: 942d
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 230
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K926253.
VACUTAINER BRAND PST PLASMA SEPARATION TUBE
K954592 · Becton Dickinson Vacutainer Systems · Nov 1995
SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM
K953994 · Becton Dickinson Vacutainer Systems · Sep 1995
VACUTAINER PLUS TUBES
K953463 · Becton Dickinson Vacutainer Systems · Sep 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION
K935564 · Sudormed, Inc. · Jul 1995
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION
K935588 · Sudormed, Inc. · Jul 1995
PRO-VENT, LINE DRAW, PULSATOR
K952516 · Smiths Industries Medical Systems, Inc. · Jul 1995
K926253 · SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
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