510(k) · Cleared
ClearedVisualeyes: Video Eye Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Technologies, Inc. · GWN Nystagmograph
Cleared on Jul 15, 1997 after a 258-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Jul 15, 1997
- Review
- 258 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK964325 Visualeyes: Video Eye MonitorMicromedical Technologies, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK122550 Ics ImpulseGn Otometrics · 2013
- Descendant · 2 generations on · 3 of its ownK151504 ICS ImpulseGn Otometrics · 2015
- Descendant · cites it directly · 3 of its ownK071973 Epley OmniaxVesticon · 2008
- Descendant · cites it directly · 1 of its ownK182214 DizzyDoctor System 1.0.0Dizzydoctor Systems, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK260566 SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc. · 2026
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122550Ics ImpulseGn Otometrics · 2013 · cites it directly4descendants
- K151504ICS ImpulseGn Otometrics · 2015 · 2 generations on3descendants
- K071973Epley OmniaxVesticon · 2008 · cites it directly3descendants
- K182214DizzyDoctor System 1.0.0Dizzydoctor Systems, LLC · 2018 · cites it directly1descendant
- K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964325 | Visualeyes: Video Eye Monitor | Micromedical Technologies, Inc. | 1997 | — |
| +1 | K122550 | Ics Impulse | Gn Otometrics | 2013 | — |
| +2 | K151504 | ICS Impulse | Gn Otometrics | 2015 | — |
| +1 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| +1 | K182214 | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | 2018 | — |
| +2 | K260566 | SMARTVERTIGO™ Vestibular Assessment System | VertigoDx, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 K260566 SMARTVERTIGO™ Vestibular Assessment Systemscore 12.1 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K122550 (Gn Otometrics, 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements.
The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient's eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses.
The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964325 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964325: Visualeyes: Video Eye Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964325
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026