Cleared Traditional

I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (K192186) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K192186 · Neurolign USA, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
109d
Days
Class 2
Risk

K192186 is an FDA 510(k) clearance for the I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-.... Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Neurolign USA, LLC (Pittsburgh, US). The FDA issued a Cleared decision on November 29, 2019 after a review of 109 days - within the typical 510(k) review window.

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 Neurolign USA, LLC devices

Submission Details

510(k) Number K192186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date November 29, 2019
Days to Decision 109 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 89d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01832714 Completed Observational Industry-sponsored

Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event

300
Patients (actual)
2
Sites
Condition studied Concussion, Mild; Concussion, Intermediate; Concussion, Severe
Eligibility All sexes · 19 Years+ · Healthy volunteers accepted
Principal investigator Alex Kiderman, PhD ME
Sponsor Neurolign (industry)
Started 2013-09-01 → Primary completion 2015-08-01 → Completed 2015-11-01
Primary outcome
Variability of latency in reflexive saccades (ms)
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - GWN Nystagmograph

All 58
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K192186.
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NeuroSwift Pro
K223047 · Neurobit Technologies Co., Ltd. · Jun 2023
Insight Infrared Video Goggles
K203082 · Vestibular First · Nov 2020
VisualEyes
K200534 · Interacoustics A/S · Aug 2020