Cleared Abbreviated

K071446 - ELECTRODE ARRAY CAP

K071446 is an FDA 510(k) clearance for ELECTRODE ARRAY CAP, manufactured by Electrode Arrays. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 405-day FDA review.

K071446 · Electrode Arrays · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
405d
Days
Class 2
Risk

K071446 is an FDA 510(k) clearance for the ELECTRODE ARRAY CAP. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Electrode Arrays (El Paso, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 405 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K071446

510(k) Number K071446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2007
Decision Date July 02, 2008
Days to Decision 405 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 149d · This submission: 405d
Pathway characteristics
Standards-based clearance path.

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 409
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K071446.
UNIVERSAL ELECTRODES
K081871 · Neurometrix, Inc. · Sep 2008
DERMABIOSAFE
K080298 · Complete Product Resources · Aug 2008
SELF-ADHESIVE ELECTRODES
K080276 · Cathay Health Care Equipment Manufacturing, Inc. · Aug 2008
FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057
K080902 · Lorenz Biotech S.P.A. · Jun 2008
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
K080386 · Columbia Scientific Development, LLC · May 2008
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
K073532 · Technomed Europe · May 2008
K071446 · ELECTRODE ARRAY CAP
Download PDF FDA Summary Electrode Arrays