Cleared Traditional

K123079 - OLYMPIC BRAINZ MONITOR

K123079 is an FDA 510(k) clearance for OLYMPIC BRAINZ MONITOR, manufactured by Excel-Tech Ltd. (Xltek). The device is a Class 2 Neurology device with product code OMA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K123079 · Excel-Tech Ltd. (Xltek) · Neurology device
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May 2013
Decision
219d
Days
Class 2
Risk

K123079 is an FDA 510(k) clearance for the OLYMPIC BRAINZ MONITOR. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on May 8, 2013 after a review of 219 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.

View all Excel-Tech Ltd. (Xltek) devices

FDA 510(k) Submission Details - K123079

510(k) Number K123079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date May 08, 2013
Days to Decision 219 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
71d slower than avg
Panel avg: 148d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMA Device Classification - Class 2, Special Controls

Product Code OMA Amplitude-integrated Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
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 - OMA Amplitude-integrated Electroencephalograph

All 8
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Neo
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