Cleared Abbreviated

K033052 - CONDUCTIVE EEG ELECTROLYTE

K033052 is an FDA 510(k) clearance for CONDUCTIVE EEG ELECTROLYTE, manufactured by Compumedics USA, Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K033052 · Compumedics USA, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K033052

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 149d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

GYB Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K033052.
NuFACE Gel Primer
K161654 · Carol Cole Company · Dec 2016
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THERA-CREAM, MODEL TCT004
K032239 · Prizm Medical, Inc. · Jul 2004
LEKTROGEL, MODEL LK3001
K030887 · Inmed Ltda. · Jun 2003
HOME CARE JELLY
K022494 · Roc Chinese-European Industrial Research Society · Dec 2002
CONDUCTIVE GEL
K022006 · The Dezac Group · Sep 2002
K033052 · CONDUCTIVE EEG ELECTROLYTE
Download PDF FDA Summary Compumedics USA, Ltd.