Cleared Traditional

K050192 - BRC SOFTWARE PRODUCT

K050192 is an FDA 510(k) clearance for BRC SOFTWARE PRODUCT, manufactured by Brc Operations Pty Limited. The device is a Class 2 Neurology device with product code OLU cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K050192 · Brc Operations Pty Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
266d
Days
Class 2
Risk

K050192 is an FDA 510(k) clearance for the BRC SOFTWARE PRODUCT. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Brc Operations Pty Limited (Indianpolis, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 266 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 - K050192

510(k) Number K050192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date October 20, 2005
Days to Decision 266 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
117d slower than avg
Panel avg: 149d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLU Device Classification - Class 2, Special Controls

Product Code OLU Normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A 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 - OLU Normalizing Quantitative Electroencephalograph Software

All 12
Devices cleared under the same product code (OLU) and FDA review panel - the closest regulatory comparables to K050192.
qEEG-Pro
K171414 · Brainmaster Technologies, Inc. · Jul 2018
BNA ANALYSIS SYSTEM
K121119 · Eiminda , Ltd. · Jul 2014
HBIDB - HUMAN BRIAN INDEX SOFTWARE
K112077 · Corscience GmbH & Co. KG · Mar 2012
NEUROGUIDE ANALYSIS SYSTEM
K041263 · Applied Neuroscience, Inc. · Aug 2004
NEUROMETRIC ANALYSIS SYSTEM
K974748 · Nxlink, Ltd. · Jul 1998
QSI 9500
K904294 · Quantified Signal Imaging, Inc. · Jul 1991
K050192 · BRC SOFTWARE PRODUCT
Download PDF FDA Summary Brc Operations Pty Li…