Cleared Traditional

K120447 - X4

K120447 is an FDA 510(k) clearance for X4, manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Neurology device with product code OMC cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K120447 · Advanced Brain Monitoring, Inc. · Neurology device
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Jun 2012
Decision
127d
Days
Class 2
Risk

K120447 is an FDA 510(k) clearance for the X4. 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 June 20, 2012 after a review of 127 days - within the typical 510(k) review window.

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.

View all Advanced Brain Monitoring, Inc. devices

FDA 510(k) Submission Details - K120447

510(k) Number K120447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2012
Decision Date June 20, 2012
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 15
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