510(k) · Cleared
ClearedBalanceback VNG System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fall Prevention Technologies, LLC · GWN Nystagmograph
Cleared on Oct 6, 2004 as substantially equivalent to K925111 (Eye Dynamics, Inc., 1994) and 1 other predicate after a 19-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Oct 6, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925111 (1994). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
- This deviceK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- Descendant · cites it directly · 2 of its ownK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
- Descendant · 2 generations on · 1 of its ownK152915 Eye-SyncSyncthink, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK181771 RightEye Vision SystemRighteye, LLC · 2018
- Descendant · cites it directly · 0 of its ownK130201 Nystagram Video Nystagmography SystemOtotronix, LLC · 2013
- Descendant · cites it directly · 0 of its ownK062015 Chronos Vision Eye Tracking Device (C-Etd)Chronos Vision · 2006
Most influential descendants
Showing 5 of 5 · See all- K070729Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007 · cites it directly2descendants
- K152915Eye-SyncSyncthink, Inc. · 2016 · 2 generations on1descendant
- K181771RightEye Vision SystemRighteye, LLC · 2018 · 3 generations on0descendants
- K130201Nystagram Video Nystagmography SystemOtotronix, LLC · 2013 · cites it directly0descendants
- K062015Chronos Vision Eye Tracking Device (C-Etd)Chronos Vision · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925111 | House Infrared/Video Electronystagmograph System | Eye Dynamics, Inc. | 1994 | — |
| 0 (this device) | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| +1 | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
| +2 | K152915 | Eye-Sync | Syncthink, Inc. | 2016 | — |
| +3 | K181771 | RightEye Vision System | Righteye, LLC | 2018 | — |
| +1 | K130201 | Nystagram Video Nystagmography System | Ototronix, LLC | 2013 | — |
| +1 | K062015 | Chronos Vision Eye Tracking Device (C-Etd) | Chronos Vision | 2006 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K925111 | House Infrared/Video Electronystagmograph SystemSummary page 1…edicate Devices: Device Name 510(k) Number Eye Dynamics, Inc. House K9251 11 Infrared/Video Electronystagmographic (ENG) System… | 1994 |
| * | K972243 | 2D Vog - Video-OculographySummary page 1…(ENG) System _ _ _ _ _ _ _ _ _ _ Sensomotoric Instruments, Inc. 2d Vog K972243 - Video-Ocutography System __________ Indications for Use: The Balan… | 1997 |
What descends from it? (5)
3 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?
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 BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042529: Balanceback VNG System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042529
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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