Cleared Traditional

K020445 - THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

K020445 is an FDA 510(k) clearance for THE ELECTRODE STORE SURFACE (CUTANEOUS)..., manufactured by The Electrode Store, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K020445 · The Electrode Store, Inc. · Neurology device
Download Printable Device Report (PDF)
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May 2002
Decision
88d
Days
Class 2
Risk

K020445 is an FDA 510(k) clearance for the THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by The Electrode Store, Inc. (Seattle, US). The FDA issued a Cleared decision on May 10, 2002 after a review of 88 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.

FDA 510(k) Submission Details - K020445

510(k) Number K020445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date May 10, 2002
Days to Decision 88 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
61d faster than avg
Panel avg: 149d · This submission: 88d
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 378
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K020445.
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
LYMPHA VISION-EXPERT
K003896 · Bexley Trading, Inc. · Apr 2002
CHIN ELECTRODE
K020468 · Dymedix, Inc. · Apr 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
K012463 · Everyway Medical Instruments Co.,Ltd · Feb 2002
K020445 · THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
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