Cleared Traditional

K872931 - TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (FDA 510(k) Clearance)

Class I Neurology device.

K872931 · Teca, Inc. · Neurology device
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Nov 1987
Decision
112d
Days
Class 1
Risk

K872931 is an FDA 510(k) clearance for the TECA/MEDELEC TTT THERMAL THRESHOLD TESTER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Teca, Inc. (Pleasantiville, US). The FDA issued a Cleared decision on November 16, 1987 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teca, Inc. devices

Submission Details

510(k) Number K872931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date November 16, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLN Device, Vibration Threshold Measurement
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.