Cleared Traditional

K260566 - SMARTVERTIGO Vestibular Assessment System

K260566 is an FDA 510(k) clearance for SMARTVERTIGO Vestibular Assessment System, manufactured by VertigoDx, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code GWN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K260566 · VertigoDx, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
161d
Days
Class 2
Risk

K260566 is an FDA 510(k) clearance for the SMARTVERTIGO™ Vestibular Assessment System. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by VertigoDx, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 161 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 VertigoDx, Inc. devices

FDA 510(k) Submission Details - K260566

510(k) Number K260566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2026
Decision Date July 30, 2026
Days to Decision 161 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 89d · This submission: 161d
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 17
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K260566.
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Synapsys VHIT
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NeuroSwift Pro
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Insight Infrared Video Goggles
K203082 · Vestibular First · Nov 2020
VisualEyes
K200534 · Interacoustics A/S · Aug 2020