Cleared Traditional

K941986 - CUTANEOUS ELECTRODE

K941986 is an FDA 510(k) clearance for CUTANEOUS ELECTRODE, manufactured by Maxxim Medical. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K941986 · Maxxim Medical · Neurology device
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Feb 1995
Decision
302d
Days
Class 2
Risk

K941986 is an FDA 510(k) clearance for the CUTANEOUS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Maxxim Medical (Sugar Land, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Maxxim Medical devices

FDA 510(k) Submission Details - K941986

510(k) Number K941986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date February 21, 1995
Days to Decision 302 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 148d · This submission: 302d
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 184
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K941986.
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · Henley Intl. · Nov 1995
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K950782 · Graphic Controls Corp. · Jun 1995
RICH-MAR CARBON ELECTRODES
K950491 · Rich-Mar Corp. · Mar 1995
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · Bio-Logic Systems Corp. · Feb 1995
EEG CUP ELECTRODE
K933808 · Cadwell Laboratories, Inc. · Dec 1994
RING ELECTRODE
K933805 · Cadwell Laboratories, Inc. · Dec 1994