Cleared Traditional

K020903 - DOCXS B SERIES ELECTRODES

K020903 is an FDA 510(k) clearance for DOCXS B SERIES ELECTRODES, manufactured by Docxs, LLC. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K020903 · Docxs, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
190d
Days
Class 2
Risk

K020903 is an FDA 510(k) clearance for the DOCXS B SERIES ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Docxs, LLC (Ukiah, US). The FDA issued a Cleared decision on September 26, 2002 after a review of 190 days - an extended review 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: 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.

FDA 510(k) Submission Details - K020903

510(k) Number K020903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2002
Decision Date September 26, 2002
Days to Decision 190 days
Submission Type Traditional
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
41d slower than avg
Panel avg: 149d · This submission: 190d
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 439
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K020903.
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K023212 · Ag Garments · Dec 2002
MODEL 4310 PSARRAY2 EEG ELECTRODE
K020670 · Physiometrix, Inc. · Oct 2002
BRAINET
K021986 · Nicolet Biomedical, Inc. · Aug 2002
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
K022197 · The Electrode Store, Inc. · Aug 2002
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020735 · Cathay International, Ltd. · Jul 2002
K020903 · DOCXS B SERIES ELECTRODES
Download PDF FDA Summary Docxs, LLC