Cleared Special

K181025 - I-Portal Neuro Otologic Test Center

Also marketed or referenced as:
I-Portal Video Nystagmography System I-Portal Video Oculography Eye Tracking System

K181025 is an FDA 510(k) clearance for I-Portal Neuro Otologic Test Center, manufactured by Neuro Kinetics, Inc.. The device is a Class 2 Neurology device with product code GWN cleared through the Special 510(k) pathway after a 97-day FDA review.

K181025 · Neuro Kinetics, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
97d
Days
Class 2
Risk

K181025 is an FDA 510(k) clearance for the I-Portal Neuro Otologic Test Center. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Neuro Kinetics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 24, 2018 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K181025

510(k) Number K181025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2018
Decision Date July 24, 2018
Days to Decision 97 days
Submission Type Special
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
52d faster than avg
Panel avg: 149d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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 Neurology devices follow this clearance model.

Regulatory Peers - GWN Nystagmograph

All 55
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K181025.
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
K192186 · Neurolign USA, LLC · Nov 2019
RightEye Vision System
K181771 · Righteye, LLC · Sep 2018
DizzyDoctor System 1.0.0
K182214 · Dizzydoctor Systems, LLC · Sep 2018
I-Portal Portable Assessment System - Nystagmograph (I-PAS)
K171884 · Neuro Kinetics, Inc. · Nov 2017
ISEN-Goggles with Data Viewer
K163270 · Isent Tech & Trading Company, Ltd. · Sep 2017
VisualEyes
K163149 · Interacoustics A/S · Apr 2017
K181025 · I-Portal Neuro Otologic Test Center
Download PDF FDA Summary Neuro Kinetics, Inc.