Cleared Traditional

K881876 - DYNAMIC CRUCIATE TESTER

K881876 is an FDA 510(k) clearance for DYNAMIC CRUCIATE TESTER, manufactured by Dyonics, Inc.. The device is a Class 1 Neurology device with product code LYH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

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

FDA 510(k) Submission Details - K881876

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 148d · This submission: 197d
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.