Cleared Traditional

K152040 - X8 System - Sleep Profiler (SP40)

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)
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

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
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.

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
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K152040.
REMI
K203827 · Epitel, Inc. · Mar 2021
Byteflies Kit
K192549 · Byteflies NV · Jun 2020
AE-120A EEG Head Set
K183529 · Nihon Kohden Corporation · Mar 2019
ENVOY PATIENT MONITOR
K024245 · Mennen Medical , Ltd. · May 2004
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
K020335 · Olympic Medical Corp. · Jun 2002
ACCESSORY TO ECG ANALYSIS SYS.
K781130 · Oxford Medilog, Inc. · Aug 1978