Cleared Traditional

MEDI-DX 7000 (K964622) - FDA 510(k) Clearance

Class I Neurology device.

K964622 · Neuro-Diagnostic Assoc. · Neurology device
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Dec 1997
Decision
378d
Days
Class 1
Risk

K964622 is an FDA 510(k) clearance for the MEDI-DX 7000. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Neuro-Diagnostic Assoc. (Laguna Beach, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 378 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Neuro-Diagnostic Assoc. devices

Submission Details

510(k) Number K964622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date December 01, 1997
Days to Decision 378 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
230d slower than avg
Panel avg: 148d · This submission: 378d
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.