Cleared Traditional

FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (K861304) - FDA 510(k) Clearance

K861304 · Infantest Corp. · Neurology device
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Sep 1986
Decision
169d
Days
-
Risk

K861304 is an FDA 510(k) clearance for the FAGAN TEST MACHINE FOR INFANT INTELLIGENCE. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Infantest Corp. (Shaker Heights, US). The FDA issued a Cleared decision on September 23, 1986 after a review of 169 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.

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Submission Details

510(k) Number K861304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date September 23, 1986
Days to Decision 169 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 148d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -