Cleared Traditional

K141316 - COGNISION EEG/EP SYSTEM

K141316 is an FDA 510(k) clearance for COGNISION EEG/EP SYSTEM, manufactured by Neuronetrix Solutions. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K141316 · Neuronetrix Solutions · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
269d
Days
Class 2
Risk

K141316 is an FDA 510(k) clearance for the COGNISION EEG/EP SYSTEM. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Neuronetrix Solutions (Austin, US). The FDA issued a Cleared decision on February 13, 2015 after a review of 269 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.

FDA 510(k) Submission Details - K141316

510(k) Number K141316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2014
Decision Date February 13, 2015
Days to Decision 269 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
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters 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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 45
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K141316.
Lifelines iEEG
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DiscoverEEG System, Model DE-401
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NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
K133995 · Neurosoft , Ltd. · Jun 2015
GALILEO NT
K142064 · Eb Neuro S.P.A. · Feb 2015
GEODESICEEG SYSTEM 400 SERIES (GES 400)
K131882 · Electrical Geodesics, Inc. · Feb 2014
LIFELINES IEEG
K123665 · Kvikna Ehf · Mar 2013