Cleared Abbreviated

CONDUCTIVE EEG ELECTROLYTE (K033052) - FDA 510(k) Clearance

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K033052 · Compumedics USA, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
79d
Days
Class 2
Risk

K033052 is an FDA 510(k) clearance for the CONDUCTIVE EEG ELECTROLYTE. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Compumedics USA, Ltd. (El Paso, US). The FDA issued a Cleared decision on December 17, 2003 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Compumedics USA, Ltd. devices

Submission Details

510(k) Number K033052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 17, 2003
Days to Decision 79 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 14
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