Cleared Traditional

GORDON DIAGNOSTIC SYSTEM MODEL I (K854903) - FDA 510(k) Clearance

K854903 · Clinical Diagnostics, Inc. · Neurology device
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Jun 1986
Decision
175d
Days
-
Risk

K854903 is an FDA 510(k) clearance for the GORDON DIAGNOSTIC SYSTEM MODEL I. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Clinical Diagnostics, Inc. (Littleton, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel. 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 Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K854903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1985
Decision Date June 02, 1986
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -