Cleared Traditional

Insight Infrared Video Goggles (K203082) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203082 · Vestibular First · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
30d
Days
Class 2
Risk

K203082 is an FDA 510(k) clearance for the Insight Infrared Video Goggles. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Vestibular First (Broomall, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vestibular First devices

Submission Details

510(k) Number K203082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2020
Decision Date November 12, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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. 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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWN Nystagmograph

All 58
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K203082.
NeuroEars-Anna™
K243709 · Neuroears, Inc. · Aug 2025
ICS Dizcovery (1091)
K242198 · Natus Medical Denmark Aps · Feb 2025
Synapsys VHIT
K242726 · Inventis S.R.L. · Jan 2025
NeuroSwift Pro
K223047 · Neurobit Technologies Co., Ltd. · Jun 2023
VisualEyes
K200534 · Interacoustics A/S · Aug 2020
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
K192186 · Neurolign USA, LLC · Nov 2019

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.