510(k) · Cleared
ClearedDizzyDoctor System 1.0.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dizzydoctor Systems, LLC · GWN Nystagmograph
Cleared on Sep 14, 2018 as substantially equivalent to K964325 (Micromedical Technologies, Inc., 1997) after a 30-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Sep 14, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964325 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964325 | Visualeyes: Video Eye Monitor | Micromedical Technologies, Inc. | 1997 | — |
| 0 (this device) | K182214 | DizzyDoctor System 1.0.0 | Dizzydoctor Systems, LLC | 2018 | — |
| +1 | K260566 | SMARTVERTIGO™ Vestibular Assessment System | VertigoDx, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 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? (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 |
|---|---|---|---|
| * | K964325 | Visualeyes: Video Eye MonitorSummary page 4…GWN Device Class: Class 2 Panel: Neurology 3. Predicate Devices: VisualEYES Video Eye Monitor; K964325; 07/15/1997; Micromedical Technologies. Indications for Use: The DizzyDoctor® System 1.0… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260566 | SMARTVERTIGO™ Vestibular Assessment System | 2026 | 0 |
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?
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in response to standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal and torsional eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182214: DizzyDoctor System 1.0.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182214
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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