Cleared Traditional

K812806 - KT-1000 DEVICE (FDA 510(k) Clearance)

Class I Neurology device.

K812806 · Medmetric Corp. · Neurology device
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Nov 1981
Decision
35d
Days
Class 1
Risk

K812806 is an FDA 510(k) clearance for the KT-1000 DEVICE. Classified as Arthrometer (product code LYH), Class I - General Controls.

Submitted by Medmetric Corp.. The FDA issued a Cleared decision on November 10, 1981 after a review of 35 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.

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Submission Details

510(k) Number K812806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date November 10, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 148d · This submission: 35d
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.