Cleared Traditional

GENUCOM (K834462) - FDA 510(k) Clearance

Class I Neurology device.

K834462 · Far Orthopedics, Inc. · Neurology device
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Feb 1984
Decision
52d
Days
Class 1
Risk

K834462 is an FDA 510(k) clearance for the GENUCOM. Classified as Arthrometer (product code LYH), Class I - General Controls.

Submitted by Far Orthopedics, Inc.. The FDA issued a Cleared decision on February 9, 1984 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1615 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Far Orthopedics, Inc. devices

Submission Details

510(k) Number K834462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date February 09, 1984
Days to Decision 52 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 148d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYH Arthrometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
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.