Cleared Traditional

K012079 - GEODESIC EEG SYSTEM, MODEL 200

K012079 is an FDA 510(k) clearance for GEODESIC EEG SYSTEM, manufactured by Electrical Geodesics, Incorporated. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K012079 · Electrical Geodesics, Incorporated · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
78d
Days
Class 2
Risk

K012079 is an FDA 510(k) clearance for the GEODESIC EEG SYSTEM, MODEL 200. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Electrical Geodesics, Incorporated (Phoenix, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 - K012079

510(k) Number K012079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2001
Decision Date September 19, 2001
Days to Decision 78 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
71d faster than avg
Panel avg: 149d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

Product Code GWQ Full-montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 184
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K012079.
84 CHANNEL EEG
K014146 · Xltek · Jan 2002
80 CHANNEL EEG
K014147 · Xltek · Jan 2002
PAM-RL
K010997 · Individual Monitoring Systems, Inc. · Oct 2001
UNIQUE AMBULATORY EEG
K010697 · Axon Systems, Inc. · Jun 2001
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1
K010669 · Thuris Corp. · Jun 2001
ACTIWARE-PLMS
K011430 · Mini-Mitter Co., Inc. · May 2001
K012079 · GEODESIC EEG SYSTEM, MODEL 200
Download PDF FDA Summary Electrical Geodesics,…