510(k) · Cleared
ClearedInsight Infrared Video Goggles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vestibular First · GWN Nystagmograph
Cleared on Nov 12, 2020 as substantially equivalent to K152112 (Interacoustics A/S, 2015) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 12, 2020
- Review
- 30 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). No later device cites it as a predicate yet.
- 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 deviceK203082 Insight Infrared Video GogglesVestibular First · 2020
View 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) | K203082 | Insight Infrared Video Goggles | Vestibular First | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 4…Product Code: GWN Device Class: Class 2 Panel: Neurology Predicate Devices Primary Predicate Device: Micromedical VisualEyes 515/ 525, K152112 VestibularFirst.com Page 1 Secondary Predi… | 2015 |
| * | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemSummary page 5…st.com Page 1 Secondary Predicate Device: Interacoustics 2D-VOGfw System (VN415b) , K072254 Indications for Use The Insight Infrared Video Goggles are intended for viewing and recording eye movements i… | 2008 |
| † | K964325 | Visualeyes: Video Eye Monitor | 1997 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- 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. 2020, 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 Insight Infrared Video Goggles are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203082: Insight Infrared Video Goggles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203082
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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