Cleared Traditional

VIBROTACTILE TESTER, MODEL NO. VTT-100 (K921560) - FDA 510(k) Clearance

Class I Neurology device.

K921560 · Topical Testing, Inc. · Neurology device
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Oct 1992
Decision
212d
Days
Class 1
Risk

K921560 is an FDA 510(k) clearance for the VIBROTACTILE TESTER, MODEL NO. VTT-100. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Topical Testing, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 30, 1992 after a review of 212 days - an extended review cycle.

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.

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Submission Details

510(k) Number K921560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date October 30, 1992
Days to Decision 212 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
64d slower than avg
Panel avg: 148d · This submission: 212d
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.