Cleared Traditional

K120450 - SLEEP PROFILER

K120450 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 218-day FDA review.

K120450 · Advanced Brain Monitoring, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
218d
Days
Class 2
Risk

K120450 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. (Dousman, US). The FDA issued a Cleared decision on September 19, 2012 after a review of 218 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.

FDA 510(k) Submission Details - K120450

510(k) Number K120450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2012
Decision Date September 19, 2012
Days to Decision 218 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
69d slower than avg
Panel avg: 149d · This submission: 218d
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 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 K120450.
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
NATUS SLEEPWORKS, MODEL 104017
K090277 · Excel-Tech Ltd. (Xltek) · Apr 2011
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
K062943 · Neurotronics, Inc. · May 2007
ALICE 5
K040595 · Respironics, Inc. · Mar 2004