510(k) · Cleared
ClearedSMARTVERTIGO™ Vestibular Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VertigoDx, Inc. · GWN Nystagmograph
Cleared on Jul 30, 2026 as substantially equivalent to K182214 (Dizzydoctor Systems, LLC, 2018) after a 161-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 30, 2026
- Review
- 161 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964325 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GWN device
- #1 K243709 NeuroEars-Anna™score 10.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182214 | DizzyDoctor System 1.0.0Summary page 6…e and software components to achieve its intended performance characteristics. 4. Legally Marketed Predicate and Reference Devices Predicate: DizzyDoctor® System 1.0.0 (K182214) Reference: Insight Infrared Video Goggles (K203082) 5. Intended Use/Indications for Use The SmartVertigo™ Vestibular Assessment… | 2018 |
| † | K203082 | Insight Infrared Video Goggles | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 21.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWN
203in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWN
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWN
1in 2025
MAUDE reports naming product code GWN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 3 | 88 | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 165 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 4 | 160 | 0 | 0 |
| 2018 | 3 | 87 | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 3 | 203 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SmartVertigo™ Vestibular Assessment System is indicated for use in the medical office, hospital, and healthcare settings for viewing and recording eye movements in patients with symptoms of dizziness caused by peripheral vestibular disorders who are under the supervision of a clinician. The device records abnormal eye movements with an iPhone camera in response to standard positional maneuvers. The device records, tracks, stores, and displays normal and abnormal eye movements, including vertical, horizontal, and torsional. This device provides no diagnosis and does not provide diagnostic recommendations.
The target population is individuals 12 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260566: SMARTVERTIGO™ Vestibular Assessment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260566
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026