Cleared Traditional

K171414 - qEEG-Pro (FDA 510(k) Clearance)

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

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
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 Peers - OLU Normalizing Quantitative Electroencephalograph Software

All 11
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