Cleared Traditional

K872931 - TECA/MEDELEC TTT THERMAL THRESHOLD TESTER

K872931 is an FDA 510(k) clearance for TECA/MEDELEC TTT THERMAL THRESHOLD TESTER, manufactured by Teca, Inc.. The device is a Class 1 Neurology device with product code LLN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K872931

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LLN Device Classification - Class 1, General Controls

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.