Cleared Traditional

K083603 - I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACK...

K083603 is an FDA 510(k) clearance for I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACK..., manufactured by Neuro Kinetics. The device is a Class 2 Ear, Nose, Throat device with product code GWN cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K083603 · Neuro Kinetics · Ear, Nose, Throat device
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Aug 2009
Decision
244d
Days
Class 2
Risk

K083603 is an FDA 510(k) clearance for the I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTA.... Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Neuro Kinetics (Pittsburgh, US). The FDA issued a Cleared decision on August 6, 2009 after a review of 244 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.1460 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuro Kinetics devices

FDA 510(k) Submission Details - K083603

510(k) Number K083603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date August 06, 2009
Days to Decision 244 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 89d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWN Device Classification - Class 2, Special Controls

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - GWN Nystagmograph

All 17
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K083603.
RightEye Vision System
K181771 · Righteye, LLC · Sep 2018
DizzyDoctor System 1.0.0
K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Neuro Otologic Test Center
K181025 · Neuro Kinetics, Inc. · Jul 2018
VARIOUS ELECTRODES
K941928 · Bio-Logic Systems Corp. · Feb 1995
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986