510(k) · Cleared
ClearedEye-Sync
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syncthink, Inc. · GWN Nystagmograph
Cleared on Jan 29, 2016 as substantially equivalent to K070729 (Fall Prevention Technologies, LLC, 2007) after a 119-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jan 29, 2016
- Review
- 119 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925111 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
- 2 generations backK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- 1 generation backK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
- This deviceK152915 Eye-SyncSyncthink, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181771 RightEye Vision SystemRighteye, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K181771RightEye Vision SystemRighteye, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925111 | House Infrared/Video Electronystagmograph System | Eye Dynamics, Inc. | 1994 | — |
| −2 | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| −1 | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
| 0 (this device) | K152915 | Eye-Sync | Syncthink, Inc. | 2016 | — |
| +1 | K181771 | RightEye Vision System | Righteye, LLC | 2018 | — |
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 |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K070729 | Balanceback Mobile Intuitive VNG SystemSummary page 4…raph Classification Name 21 C.F.R. 882.1460 Nystagmograph Product Code GWN Predicate Device Fall Prevention Technologies, LLC balanceback Mobile Intuitive VNG System (K070729) Intended Use / Indications for Use The EYE-SYNC is intended for recording, viewing, and analyzing eye movements in support of i… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181771 | RightEye Vision System | 2018 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K181771 (Righteye, LLC, 2018) has gone furthest, with 0 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. 2016, 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 EYE-SYNC 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/K152915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152915: Eye-Sync.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152915
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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