Cleared Traditional

K131383 - X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE

K131383 is an FDA 510(k) clearance for X10 HEADSET WITH X-SERIES BASIC SOFTWARE, manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K131383 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
197d
Days
Class 2
Risk

K131383 is an FDA 510(k) clearance for the X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOF.... Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Dousman, US). The FDA issued a Cleared decision on November 27, 2013 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K131383

510(k) Number K131383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date November 27, 2013
Days to Decision 197 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
48d slower than avg
Panel avg: 149d · This submission: 197d
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 164
Devices cleared under the same product code (GWQ) and FDA review panel - the closest regulatory comparables to K131383.
BWMINI EEG, BWMINIHST, BWMINI PSG
K131335 · Neurovirtual USA, Inc. · Feb 2015
TREZ_HD
K131266 · Excel-Tech Ltd. (Xltek) · Feb 2014
CADWELL FLEX EEG/PSG
K133355 · Cadwell Industries, Inc. · Jan 2014
CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
K122196 · Blackrock Neuromed, LLC · May 2013
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
K120888 · Nihon Kohden Corp. · Nov 2012
MICROEEG SYSTEM
K112817 · Bio-Signal Group Corporation · Jun 2012