Cleared Traditional

K842271 - ELECTRODE, SURFACE EEG ELECTRODE

K842271 is an FDA 510(k) clearance for ELECTRODE, manufactured by Durden Enterprises, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K842271 · Durden Enterprises, Inc. · Neurology device
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Jul 1984
Decision
42d
Days
Class 2
Risk

K842271 is an FDA 510(k) clearance for the ELECTRODE, SURFACE EEG ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Durden Enterprises, Inc. (Walker, US). The FDA issued a Cleared decision on July 20, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Durden Enterprises, Inc. devices

FDA 510(k) Submission Details - K842271

510(k) Number K842271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1984
Decision Date July 20, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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.

Regulatory Peers - GXY Electrode, Cutaneous

All 318
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K842271.
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850108 · Nicolet Biomedical Instruments · Apr 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984
NEURO EASE
K831785 · Andover Medical, Inc. · Jun 1983
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · 3M Company · May 1983
ELECTRODE 3799
K831046 · Medtronic Vascular · Apr 1983