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 Apr 26, 2017 as substantially equivalent to K152112 (Interacoustics A/S, 2015) and 1 other predicate after a 168-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 26, 2017
- Review
- 168 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972243 (1997). 4 ancestors in all, the oldest K964646 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK972243 2D Vog - Video-OculographySensomotoric Instruments, GmbH · 1997
- 2 generations backK072254 VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemInteracoustics A/S · 2008
- 1 generation backK152112 VisualEyesInteracoustics A/S · 2015
- This deviceK163149 VisualEyesInteracoustics A/S · 2017
- Descendant · cites it directly · 1 of its ownK200534 VisualEyesInteracoustics A/S · 2020
- Descendant · 2 generations on · 0 of its ownK223047 NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972243 | 2D Vog - Video-Oculography | Sensomotoric Instruments, GmbH | 1997 | — |
| −2 | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System | Interacoustics A/S | 2008 | — |
| −1 | K152112 | VisualEyes | Interacoustics A/S | 2015 | — |
| 0 (this device) | K163149 | VisualEyes | Interacoustics A/S | 2017 | — |
| +1 | K200534 | VisualEyes | Interacoustics A/S | 2020 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K152112 | VisualEyesSummary page 5…ccording to 21 CFR 882.1460) Predicate Device 1: Predicate Device VisualEyes 515/ 525 Manufacturer Interacoustics A/S 510(k) No. K152112 Date Cleared 12/29/2015 Predicate Device 2: Predicate Device VIDEO EYE TRAKKER Manufacturer… | 2015 |
| * | K964646 | Video Eye TrakkerSummary page 5…12/29/2015 Predicate Device 2: Predicate Device VIDEO EYE TRAKKER Manufacturer Micromedical Technologies Inc. 510(k) No. K964646 Date Cleared 07/15/1997 510(k) Summary p. 1 VisualEyes… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200534 | VisualEyes | 2020 | 1 |
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 20 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200534 (Interacoustics A/S, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152112.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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+
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163149: VisualEyes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163149
Report an extraction error
Are you the manufacturer?
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