510(k) · Cleared
ClearedVisualEyes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · GWN Nystagmograph
Cleared on Aug 12, 2020 as substantially equivalent to K163149 (Interacoustics A/S, 2017) after a 163-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Aug 12, 2020
- Review
- 163 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972243 (1997). 5 ancestors in all, the oldest K964646 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK972243 2D Vog - Video-OculographySensomotoric Instruments, GmbH · 1997
- 3 generations backK072254 VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemInteracoustics A/S · 2008
- 2 generations backK152112 VisualEyesInteracoustics A/S · 2015
- 1 generation backK163149 VisualEyesInteracoustics A/S · 2017
- This deviceK200534 VisualEyesInteracoustics A/S · 2020
- Descendant · cites it directly · 0 of its ownK223047 NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223047NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972243 | 2D Vog - Video-Oculography | Sensomotoric Instruments, GmbH | 1997 | — |
| −3 | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System | Interacoustics A/S | 2008 | — |
| −2 | K152112 | VisualEyes | Interacoustics A/S | 2015 | — |
| −1 | K163149 | VisualEyes | Interacoustics A/S | 2017 | — |
| 0 (this device) | K200534 | VisualEyes | Interacoustics A/S | 2020 | — |
| +1 | K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K163149 | VisualEyesSummary page 5…ording to 21 CFR 882.1460) Predicate Device: Predicate Device VisualEyes 505/515/ 525 Manufacturer Interacoustics A/S 510(k) No. K163149 Date Cleared 04/26/2017 Reference devices: Reference Device VIDEO EYE TRAKKER (Aka Spectrum) Manufactur… | 2017 |
| † | K964646 | Video Eye Trakker | 1997 |
| † | K131681 | Eyeseecam Vhit | 2013 |
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 |
|---|---|---|---|
| K223047 | NeuroSwift Pro | 2023 | 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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K223047 (Neurobit Technologies Co., Ltd., 2023) has gone furthest, with 0 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. 2020, 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 VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age and above
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200534 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200534: VisualEyes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200534
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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