Cleared Traditional

K071118 - GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE

K071118 is an FDA 510(k) clearance for GOLD CUP ELECTRODE, manufactured by Ives Eeg Solutions, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K071118 · Ives Eeg Solutions, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
140d
Days
Class 2
Risk

K071118 is an FDA 510(k) clearance for the GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING .... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ives Eeg Solutions, Inc. (Manotick, Ontario, CA). The FDA issued a Cleared decision on September 7, 2007 after a review of 140 days - within the typical 510(k) review window.

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. 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 Ives Eeg Solutions, Inc. devices

FDA 510(k) Submission Details - K071118

510(k) Number K071118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2007
Decision Date September 07, 2007
Days to Decision 140 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 148d · This submission: 140d
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 250
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K071118.
GE ENTROPY SENSOR
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GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc. · Feb 2007
BIS BILATERAL SENSOR
K062692 · Aspect Medical Systems, Inc. · Dec 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd. · Aug 2006