510(k) · Cleared
Cleared2D Vog - Video-Oculography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensomotoric Instruments, GmbH · GWN Nystagmograph
Cleared on Sep 10, 1997 after an 86-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK972243 2D Vog - Video-OculographySensomotoric Instruments, GmbH · 1997
- Descendant · cites it directly · 6 of its ownK072254 VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemInteracoustics A/S · 2008
- Descendant · cites it directly · 5 of its ownK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- Descendant · 2 generations on · 4 of its ownK152112 VisualEyesInteracoustics A/S · 2015
- Descendant · 3 generations on · 2 of its ownK163149 VisualEyesInteracoustics A/S · 2017
- Descendant · 2 generations on · 2 of its ownK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072254VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemInteracoustics A/S · 2008 · cites it directly6descendants
- K042529Balanceback VNG SystemFall Prevention Technologies, LLC · 2004 · cites it directly5descendants
- K152112VisualEyesInteracoustics A/S · 2015 · 2 generations on4descendants
- K163149VisualEyesInteracoustics A/S · 2017 · 3 generations on2descendants
- K070729Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972243 | 2D Vog - Video-Oculography | Sensomotoric Instruments, GmbH | 1997 | — |
| +1 | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System | Interacoustics A/S | 2008 | — |
| +1 | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| +2 | K152112 | VisualEyes | Interacoustics A/S | 2015 | — |
| +3 | K163149 | VisualEyes | Interacoustics A/S | 2017 | — |
| +2 | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | — | House Infrared/Video Electronystagmograph System Named without a submission number |
What descends from it? (12)
See all 123 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, K072254 (Interacoustics A/S, 2008) has gone furthest, with 6 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 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972243: 2D Vog - Video-Oculography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972243
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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