Cleared Traditional

K083603 - I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 90d · 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 47
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K083603.
EYESEECAM VHIT
K131681 · Interacoustics A/S · Sep 2013
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM
K130201 · Ototronix, LLC · Apr 2013
ICS IMPULSE
K122550 · Gn Otometrics · Feb 2013
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
K072254 · Interacoustics A/S · Feb 2008
EYETRACKER/IDEAS
K070670 · S.A. Instrumentation Difra · Sep 2007
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
K070729 · Fall Prevention Technologies, LLC · Mar 2007