Cleared Special

K022785 - EPOCH XP NEUROLOGICAL WORKSTATION (FDA 510(k) Clearance)

Also includes:
EPOCH XP LITE NEUROLOGICAL WORKSTATION

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

K022785 · Axon Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
48d
Days
Class 2
Risk

K022785 is an FDA 510(k) clearance for the EPOCH XP NEUROLOGICAL WORKSTATION. 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 9, 2002 after a review of 48 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Axon Systems, Inc. devices

Submission Details

510(k) Number K022785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2002
Decision Date October 09, 2002
Days to Decision 48 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 148d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

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

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