510(k) · Cleared
ClearedRightEye Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Righteye, LLC · GWN Nystagmograph
Cleared on Sep 28, 2018 as substantially equivalent to K152915 (Syncthink, Inc., 2016) after an 87-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Sep 28, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925111 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
- 3 generations backK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- 2 generations backK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
- 1 generation backK152915 Eye-SyncSyncthink, Inc. · 2016
- This deviceK181771 RightEye Vision SystemRighteye, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925111 | House Infrared/Video Electronystagmograph System | Eye Dynamics, Inc. | 1994 | — |
| −3 | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| −2 | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
| −1 | K152915 | Eye-Sync | Syncthink, Inc. | 2016 | — |
| 0 (this device) | K181771 | RightEye Vision System | Righteye, LLC | 2018 | — |
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? (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 |
|---|---|---|---|
| * | K152915 | Eye-SyncSummary page 4…Nystagmograph Classification Name: 21 CFR 882.1460 Device Class: Class II Product Code: GWN Predicate Device: EYE-SYNC (K152915) SyncThink, Inc. Device Description: RightEye Vision System detects involuntary eye movement behavio… | 2016 |
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 24 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 RightEye Vision System is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181771 · printed Nov 3, 2026
Cite this page
510(k) Report. “K181771: RightEye Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K181771
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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