Cleared Traditional

K171414 - qEEG-Pro

K171414 is the FDA 510(k) clearance for qEEG-Pro by Brainmaster Technologies, Inc.. It is a Class 2 Neurology device (product code OLU) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K171414 · Brainmaster Technologies, Inc. · Neurology device
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Jul 2018
Decision
412d
Days
Class 2
Risk

K171414 is an FDA 510(k) clearance for the qEEG-Pro. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Brainmaster Technologies, Inc. (Bedford, US). The FDA issued a Cleared decision on July 1, 2018 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Brainmaster Technologies, Inc. devices

Submission Details

510(k) Number K171414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date July 01, 2018
Days to Decision 412 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
264d slower than avg
Panel avg: 148d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Mdi Consultants, Inc.
Maria Griffin

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.