Cleared Traditional

K935564 - SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION

K935564 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 603-day FDA review.

K935564 · Sudormed, Inc. · Toxicology device
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Jul 1995
Decision
603d
Days
Class 2
Risk

K935564 is an FDA 510(k) clearance for the SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRA.... 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 603 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

FDA 510(k) Submission Details - K935564

510(k) Number K935564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date July 14, 1995
Days to Decision 603 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
516d slower than avg
Panel avg: 87d · This submission: 603d
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 159
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K935564.
GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
K960858 · Greiner America, Inc. · Aug 1996
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · Becton Dickinson Vacutainer Systems · Mar 1996
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
K936240 · Sudormed, Inc. · Mar 1996
PRO-VENT, LINE DRAW, PULSATOR
K952516 · Smiths Industries Medical Systems, Inc. · Jul 1995
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · Sherwood Medical Co. · May 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995