Cleared Traditional

K152040 - X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

K152040 is an FDA 510(k) clearance for X8 System - Sleep Profiler (SP40), 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 100-day FDA review.

K152040 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
100d
Days
Class 2
Risk

K152040 is an FDA 510(k) clearance for the X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8.... Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 100 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.

FDA 510(k) Submission Details - K152040

510(k) Number K152040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date October 30, 2015
Days to Decision 100 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
49d faster than avg
Panel avg: 149d · This submission: 100d
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 Consultant

Pathway Regulatory Consulting, LLC
ADRIENNE LENZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OMC Reduced- Montage Standard Electroencephalograph

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