Cleared Traditional

K863395 - WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER (FDA 510(k) Clearance)

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

K863395 · Wescor, Inc. · Toxicology device
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May 1988
Decision
629d
Days
Class 2
Risk

K863395 is an FDA 510(k) clearance for the WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on May 24, 1988 after a review of 629 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1170 - 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 Wescor, Inc. devices

Submission Details

510(k) Number K863395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date May 24, 1988
Days to Decision 629 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
542d slower than avg
Panel avg: 87d · This submission: 629d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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.