Cleared Traditional

K970180 - VSA 3000 VIBRATORYN SENSORY ANALYZER (FDA 510(k) Clearance)

Class I Neurology device.

K970180 · Eare Consulting Service · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
98d
Days
Class 1
Risk

K970180 is an FDA 510(k) clearance for the VSA 3000 VIBRATORYN SENSORY ANALYZER. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on April 25, 1997 after a review of 98 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.

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Submission Details

510(k) Number K970180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date April 25, 1997
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
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.