Cleared Traditional

PHOENIX DIGITAL EEG (K002316) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002316 · Axon Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
87d
Days
Class 2
Risk

K002316 is an FDA 510(k) clearance for the PHOENIX DIGITAL EEG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Axon Systems, Inc. (Hauppauge, US). The FDA issued a Cleared decision on October 26, 2000 after a review of 87 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.

View all Axon Systems, Inc. devices

Submission Details

510(k) Number K002316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date October 26, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 34
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K002316.
Micromed BRAIN QUICK system
K171384 · Micromed S.P.A. · Feb 2018
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · Nihon Kohden America, Inc. · Mar 2012
ENTROPY EASYFIT SENSOR
K103129 · Ge Healthcare · Jul 2011
NIHON KOHDEN ELECTROENCEPHALOGRAPH
K944678 · Nihon Kohden America, Inc. · May 1995
NEUROFAX EEG 5532
K915096 · Nihon Kohden America, Inc. · Mar 1992
EEG-5400 SERIES
K902550 · Nihon Kohden America, Inc. · Mar 1991