Cleared Traditional

K942059 - KT2000 KNEE LIGAMENT ARTHROMETER

K942059 is an FDA 510(k) clearance for KT2000 KNEE LIGAMENT ARTHROMETER, manufactured by Medmetric Corp.. The device is a Class 1 Neurology device with product code LYH cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K942059 · Medmetric Corp. · Neurology device
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Sep 1994
Decision
144d
Days
Class 1
Risk

K942059 is an FDA 510(k) clearance for the KT2000 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 September 20, 1994 after a review of 144 days - within the typical 510(k) review window.

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.

View all Medmetric Corp. devices

FDA 510(k) Submission Details - K942059

510(k) Number K942059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1994
Decision Date September 20, 1994
Days to Decision 144 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
4d faster than avg
Panel avg: 148d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

LYH Device Classification - Class 1, General Controls

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.