Cleared Traditional

K253015 - Cognitive Function Neuroimaging (cfNI) ...

K253015 is an FDA 510(k) clearance for Cognitive Function Neuroimaging (cfNI) ..., manufactured by VoxNeuro, Inc.. 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.

K253015 · VoxNeuro, Inc. · Neurology device
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Jun 2026
Decision
266d
Days
Class 2
Risk

K253015 is an FDA 510(k) clearance for the Cognitive Function Neuroimaging (cfNI) Software (1.0.0). Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by VoxNeuro, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 12, 2026 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.

View all VoxNeuro, Inc. devices

FDA 510(k) Submission Details - K253015

510(k) Number K253015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date June 12, 2026
Days to Decision 266 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
118d slower than avg
Panel avg: 148d · 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.

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