Cleared Traditional

K092039 - IDENTEVENT, VERSION 1.0G (FDA 510(k) Clearance)

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

K092039 · Optima Neuroscience, Inc. · Neurology device
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Oct 2009
Decision
102d
Days
Class 2
Risk

K092039 is an FDA 510(k) clearance for the IDENTEVENT, VERSION 1.0G. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Optima Neuroscience, Inc. (Newberry, US). The FDA issued a Cleared decision on October 16, 2009 after a review of 102 days - within the typical 510(k) review window.

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 Optima Neuroscience, Inc. devices

Submission Details

510(k) Number K092039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date October 16, 2009
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By 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 - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 40
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