Cleared Traditional

VisualEyes (K200534) - FDA 510(k) Clearance

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

K200534 · Interacoustics A/S · Ear, Nose, Throat device
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Aug 2020
Decision
163d
Days
Class 2
Risk

K200534 is an FDA 510(k) clearance for the VisualEyes. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on August 12, 2020 after a review of 163 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 Interacoustics A/S devices

Submission Details

510(k) Number K200534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date August 12, 2020
Days to Decision 163 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
74d slower than avg
Panel avg: 89d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - GWN Nystagmograph

All 58
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K200534.
NeuroEars-Anna™
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ICS Dizcovery (1091)
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Synapsys VHIT
K242726 · Inventis S.R.L. · Jan 2025
NeuroSwift Pro
K223047 · Neurobit Technologies Co., Ltd. · Jun 2023
Insight Infrared Video Goggles
K203082 · Vestibular First · Nov 2020
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
K192186 · Neurolign USA, LLC · Nov 2019