Cleared Traditional

K942059 - KT2000 KNEE LIGAMENT ARTHROMETER (FDA 510(k) Clearance)

Class I Neurology device.

K942059 · Medmetric Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.