510(k) · Cleared
ClearedVideo Eye Trakker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Technologies, Inc. · GWN Nystagmograph
Cleared on Jul 15, 1997 after a 237-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 15, 1997
- Review
- 237 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK964646 Video Eye TrakkerMicromedical Technologies, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK152112 VisualEyesInteracoustics A/S · 2015
- Descendant · cites it directly · 2 of its ownK163149 VisualEyesInteracoustics A/S · 2017
- Descendant · 2 generations on · 1 of its ownK200534 VisualEyesInteracoustics A/S · 2020
- Descendant · 3 generations on · 0 of its ownK223047 NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK203082 Insight Infrared Video GogglesVestibular First · 2020
Most influential descendants
Showing 5 of 5 · See all- K152112VisualEyesInteracoustics A/S · 2015 · cites it directly4descendants
- K163149VisualEyesInteracoustics A/S · 2017 · cites it directly2descendants
- K200534VisualEyesInteracoustics A/S · 2020 · 2 generations on1descendant
- K223047NeuroSwift ProNeurobit Technologies Co., Ltd. · 2023 · 3 generations on0descendants
- K203082Insight Infrared Video GogglesVestibular First · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964646 | Video Eye Trakker | Micromedical Technologies, Inc. | 1997 | — |
| +1 | K152112 | VisualEyes | Interacoustics A/S | 2015 | — |
| +1 | K163149 | VisualEyes | Interacoustics A/S | 2017 | — |
| +2 | K200534 | VisualEyes | Interacoustics A/S | 2020 | — |
| +3 | K223047 | NeuroSwift Pro | Neurobit Technologies Co., Ltd. | 2023 | — |
| +2 | K203082 | Insight Infrared Video Goggles | Vestibular First | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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, K152112 (Interacoustics A/S, 2015) has gone furthest, with 4 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 device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a physiologic signal amplifier for monitoring eye position.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964646: Video Eye Trakker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964646
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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