Cleared Traditional

K152040 - X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152040 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (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.

View all Advanced Brain Monitoring, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K152040.
NX01 (NX01)
K251550 · Naox Technologies Sas · Nov 2025
SignalNED System (Model RE)
K251726 · Forest Devices, Inc. · Sep 2025
REMI Remote EEG Monitoring System
K243185 · Epitel · Mar 2025
Natus BrainWatch System
K242930 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Nov 2024
QUEX ED
K232779 · Qx World, Ltd. · Oct 2024
SignalNED System (Model RE)
K242306 · Forest Devices, Inc. · Sep 2024