510(k) · Cleared
ClearedIcs Medical Model VG-30 Video Goggles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ics Medical · GWN Nystagmograph
Cleared on Dec 10, 2001 as substantially equivalent to K991497 (Ics Medical Corp., 1999) after a 90-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Dec 10, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991497 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991497 Ics Medical Chartr Eng/VNG Diagnostic SystemIcs Medical Corp. · 1999
- This deviceK013060 Ics Medical Model VG-30 Video GogglesIcs Medical · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991497 | Ics Medical Chartr Eng/VNG Diagnostic System | Ics Medical Corp. | 1999 | — |
| 0 (this device) | K013060 | Ics Medical Model VG-30 Video Goggles | Ics Medical | 2001 | — |
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 |
|---|---|---|---|
| * | K991497 | Ics Medical Chartr Eng/VNG Diagnostic SystemSummary page 1…nd measure eye movements during testing of vestibular function. The Model VG-30 Video Goggles are substantially equivalent to the Model VG-10 Goggles cleared in 510(k); K991497. Comparison of Similarities and Differences of Our New Medical Device to the Predicate Device: ICS Video Goggle ICS Medical Mod… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K991497.
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 ICS Medical Model VG-30 Video Goggles are intended to provide video
signals of patient's eyes thus making it possible to observe, record, and measure
eye movements during testing of vestibular function.
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/K013060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013060: Ics Medical Model VG-30 Video Goggles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026