Cleared Traditional

K153412 - Sleep Profiler

K153412 is an FDA 510(k) clearance for Sleep Profiler, manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Neurology device with product code OLZ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K153412 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
110d
Days
Class 2
Risk

K153412 is an FDA 510(k) clearance for the Sleep Profiler. Classified as Automatic Event Detection Software For Polysomnograph With Electroencephalograph (product code OLZ), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 14, 2016 after a review of 110 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 - K153412

510(k) Number K153412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date March 14, 2016
Days to Decision 110 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
39d faster than avg
Panel avg: 149d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLZ Device Classification - Class 2, Special Controls

Product Code OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Electroencephalograph And Polysomongraph Signals In Order To Aid In Identification Of Such Events And Annotation Of Prolonged Psg Traces; Automatically Calculate Simple Measures Obtained From Recorded Signals (e.g. Magnitude, Time, Frequency And Simple Statistical Measures Of Marked Events); All Output Subject To Verification By Qualified User
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 - OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph

All 33
Devices cleared under the same product code (OLZ) and FDA review panel - the closest regulatory comparables to K153412.
EnsoSleep
K162627 · Ensodata, Inc. · Mar 2017
RemLogic
K162140 · Embla Systems · Dec 2016
SANDMAN ELITE
K153353 · Embla Systems · Jun 2016
Sleepware G3
K142988 · Respironics, Inc. · Mar 2015
Zmachine
K142825 · Consolidated Research of Richmond, Inc. · Jan 2015
SLEEP PROFILER
K130007 · Advanced Brain Monitoring, Inc. · Apr 2013