Cleared Traditional

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K912283) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912283 · Chalgren Enterprises, Inc. · Neurology device
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Mar 1992
Decision
298d
Days
Class 2
Risk

K912283 is an FDA 510(k) clearance for the DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on March 16, 1992 after a review of 298 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Chalgren Enterprises, Inc. devices

Submission Details

510(k) Number K912283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date March 16, 1992
Days to Decision 298 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
150d slower than avg
Panel avg: 148d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.