Cleared Traditional

K191432 - cortiQ PRO

K191432 is an FDA 510(k) clearance for cortiQ PRO, manufactured by G.Tec Medical Engineering GmbH. The device is a Class 2 Neurology device with product code OLU cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K191432 · G.Tec Medical Engineering GmbH · Neurology device
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Jan 2020
Decision
240d
Days
Class 2
Risk

K191432 is an FDA 510(k) clearance for the cortiQ PRO. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by G.Tec Medical Engineering GmbH (Schiedlberg, AT). The FDA issued a Cleared decision on January 24, 2020 after a review of 240 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 G.Tec Medical Engineering GmbH devices

FDA 510(k) Submission Details - K191432

510(k) Number K191432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date January 24, 2020
Days to Decision 240 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
92d slower than avg
Panel avg: 148d · This submission: 240d
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.

Regulatory Peers - OLU Normalizing Quantitative Electroencephalograph Software

All 10
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