Cleared Special

K130013 - X4 SYSTEM

K130013 is an FDA 510(k) clearance for X4 SYSTEM, manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Neurology device with product code OMC cleared through the Special 510(k) pathway after a 29-day FDA review.

K130013 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
29d
Days
Class 2
Risk

K130013 is an FDA 510(k) clearance for the X4 SYSTEM. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Dousman, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 29 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.

FDA 510(k) Submission Details - K130013

510(k) Number K130013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date January 31, 2013
Days to Decision 29 days
Submission Type Special
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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OMC Device Classification - Class 2, Special Controls

Product Code OMC Reduced- 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 User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 27
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K130013.
Ceribell Pocket EEG Device
K170363 · Ceribell, Inc. · May 2017
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
K152040 · Advanced Brain Monitoring, Inc. · Oct 2015
IEEG
K131944 · Jordan Neuroscience, Inc. · Apr 2014
X4
K120447 · Advanced Brain Monitoring, Inc. · Jun 2012
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967 · Neuralynx, Inc. · Jun 2011
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701
K092477 · Neurowave Systems, Inc. · Oct 2010