Cleared Traditional

K172858 - PreOp

K172858 is an FDA 510(k) clearance for PreOp, manufactured by Epilog. The device is a Class 2 Neurology device with product code OLX cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K172858 · Epilog · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K172858

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
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.

OLX Device Classification - Class 2, Special Controls

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 Consultant

Qserve Group, Us, Inc.
Patsy Trisler

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 - OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

All 23
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