Cleared Traditional

K943197 - KT1000/S KNEE LIGAMENT ARTHROMETER (FDA 510(k) Clearance)

Class I Neurology device.

K943197 · Medmetric Corp. · Neurology device
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Mar 1995
Decision
240d
Days
Class 1
Risk

K943197 is an FDA 510(k) clearance for the KT1000/S KNEE LIGAMENT ARTHROMETER. Classified as Arthrometer (product code LYH), Class I - General Controls.

Submitted by Medmetric Corp. (San Diego, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 240 days - an extended review 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: 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 K943197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date March 02, 1995
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 148d · This submission: 240d
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.