510(k) · Cleared
ClearedVN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · GWN Nystagmograph
Cleared on Feb 5, 2008 as substantially equivalent to K972243 (Sensomotoric Instruments, GmbH, 1997) after a 175-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Feb 5, 2008
- Review
- 175 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972243 (1997). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK972243 2D Vog - Video-OculographySensomotoric Instruments, GmbH · 1997
- This deviceK072254 VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemInteracoustics A/S · 2008
- Descendant · cites it directly · 4 of its ownK152112 VisualEyesInteracoustics A/S · 2015
- Descendant · 2 generations on · 2 of its ownK163149 VisualEyesInteracoustics A/S · 2017
- Descendant · 3 generations on · 1 of its ownK200534 VisualEyesInteracoustics A/S · 2020
- Descendant · 4 generations on · 0 of its ownK223047 NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK203082 Insight Infrared Video GogglesVestibular First · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152112VisualEyesInteracoustics A/S · 2015 · cites it directly4descendants
- K163149VisualEyesInteracoustics A/S · 2017 · 2 generations on2descendants
- K200534VisualEyesInteracoustics A/S · 2020 · 3 generations on1descendant
- K223047NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023 · 4 generations on0descendants
- K203082Insight Infrared Video GogglesVestibular First · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972243 | 2D Vog - Video-Oculography | Sensomotoric Instruments, GmbH | 1997 | — |
| 0 (this device) | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System | Interacoustics A/S | 2008 | — |
| +1 | K152112 | VisualEyes | Interacoustics A/S | 2015 | — |
| +2 | K163149 | VisualEyes | Interacoustics A/S | 2017 | — |
| +3 | K200534 | VisualEyes | Interacoustics A/S | 2020 | — |
| +4 | K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | 2023 | — |
| +1 | K203082 | Insight Infrared Video Goggles | Vestibular First | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K972243 | 2D Vog - Video-OculographySummary page 1…SUBSTANTIAL EQUIVALENCE Predicate Device Manufacture 510(k) No. Date Cleared 2D VOG- SensoMotoric K972243 09/10/1997 Videooculography Instruments 2D-VOGFw System 510k Notification… | 1997 |
What descends from it? (6)
3 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?
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
VN415m, VN415b, VO425m, VO425b systems provide information to assist in the
Oculographic evaluation, diagnosis and documentation of vestibular disorders.
Nystagmus of the eye is recorded by use of goggle mounted 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072254
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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