Cleared Traditional

K172858 - PreOp (FDA 510(k) Clearance)

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

K172858 · Epilog · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
110d
Days
Class 2
Risk

K172858 is an FDA 510(k) clearance for the PreOp. Classified as Source Localization Software For Electroencephalograph Or Magnetoencephalograph (product code OLX), Class II - Special Controls.

Submitted by Epilog (Ghent, BE). The FDA issued a Cleared decision on January 8, 2018 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.

View all Epilog devices

Submission Details

510(k) Number K172858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2017
Decision Date January 08, 2018
Days to Decision 110 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
38d faster than avg
Panel avg: 148d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Correlation Of Electrical Activity Of The Brain Using Various Neuroimaging Modalities For Source-localization
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 - OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

All 23
Devices cleared under the same product code (OLX) and FDA review panel - the closest regulatory comparables to K172858.
PreOp v3
K252565 · Clouds of Care · Feb 2026
NeuroMatch
K250239 · LVIS Corporation · May 2025
Sourcerer
K241513 · Brain Electrophysiology Laboratory Company, LLC · Sep 2024
TRIUX™ neo (NM27000N )
K233985 · Megin OY · May 2024
RICOH MEG
K210199 · Ricoh Company, Ltd. · Jul 2021
EZTrack
K201910 · Neurologic, LLC · Dec 2020