Cleared Traditional

TSA 2001 THERMAL SENSORY ANALYZER (K922052) - FDA 510(k) Clearance

Class I Neurology device.

K922052 · Medoc Corp. · Neurology device
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Oct 1993
Decision
535d
Days
Class 1
Risk

K922052 is an FDA 510(k) clearance for the TSA 2001 THERMAL SENSORY ANALYZER. Classified as Test, Temperature Discrimination (product code LQW), Class I - General Controls.

Submitted by Medoc Corp. (Eilat, IL). The FDA issued a Cleared decision on October 21, 1993 after a review of 535 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - the FDA neurology 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 Neurology submissions.

View all Medoc Corp. devices

Submission Details

510(k) Number K922052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date October 21, 1993
Days to Decision 535 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 148d · This submission: 535d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQW Test, Temperature Discrimination
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.