510(k) · Cleared
ClearedHouse Infrared/Video Electronystagmograph System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eye Dynamics, Inc. · GWN Nystagmograph
Cleared on Mar 23, 1994 after a 530-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 23, 1994
- Review
- 530 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- Descendant · 2 generations on · 2 of its ownK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
- Descendant · 3 generations on · 1 of its ownK152915 Eye-SyncSyncthink, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK181771 RightEye Vision SystemRighteye, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK130201 Nystagram Video Nystagmography SystemOtotronix, LLC · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042529Balanceback VNG SystemFall Prevention Technologies, LLC · 2004 · cites it directly5descendants
- K070729Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007 · 2 generations on2descendants
- K152915Eye-SyncSyncthink, Inc. · 2016 · 3 generations on1descendant
- K181771RightEye Vision SystemRighteye, LLC · 2018 · 4 generations on0descendants
- K130201Nystagram Video Nystagmography SystemOtotronix, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925111 | House Infrared/Video Electronystagmograph System | Eye Dynamics, Inc. | 1994 | — |
| +1 | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| +2 | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
| +3 | K152915 | Eye-Sync | Syncthink, Inc. | 2016 | — |
| +4 | K181771 | RightEye Vision System | Righteye, LLC | 2018 | — |
| +2 | K130201 | Nystagram Video Nystagmography System | Ototronix, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 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, K042529 (Fall Prevention Technologies, LLC, 2004) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K925111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925111: House Infrared/Video Electronystagmograph System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925111
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026