Cleared Traditional

K881876 - DYNAMIC CRUCIATE TESTER (FDA 510(k) Clearance)

Class I Neurology device.

K881876 · Dyonics, Inc. · Neurology device
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Nov 1988
Decision
197d
Days
Class 1
Risk

K881876 is an FDA 510(k) clearance for the DYNAMIC CRUCIATE TESTER. Classified as Arthrometer (product code LYH), Class I - General Controls.

Submitted by Dyonics, Inc. (Andover, US). The FDA issued a Cleared decision on November 17, 1988 after a review of 197 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.

View all Dyonics, Inc. devices

Submission Details

510(k) Number K881876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1988
Decision Date November 17, 1988
Days to Decision 197 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 148d · This submission: 197d
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.