Cleared Traditional

SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION (K935588) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935588 · Sudormed, Inc. · Toxicology device
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Jul 1995
Decision
604d
Days
Class 2
Risk

K935588 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PER.... 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 604 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.

View all Sudormed, Inc. devices

Submission Details

510(k) Number K935588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date July 14, 1995
Days to Decision 604 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
517d slower than avg
Panel avg: 87d · This submission: 604d
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 Toxicology devices follow this clearance model.

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

All 236
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