510(k) · Cleared
ClearedBalanceback Mobile Intuitive 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 Mar 30, 2007 as substantially equivalent to K042529 (Fall Prevention Technologies, LLC, 2004) after a 15-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 30, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925111 (1994). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
- 1 generation backK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
- This deviceK070729 Balanceback Mobile Intuitive VNG SystemFall Prevention Technologies, LLC · 2007
- Descendant · cites it directly · 1 of its ownK152915 Eye-SyncSyncthink, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK181771 RightEye Vision SystemRighteye, LLC · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925111 | House Infrared/Video Electronystagmograph System | Eye Dynamics, Inc. | 1994 | — |
| −1 | K042529 | Balanceback VNG System | Fall Prevention Technologies, LLC | 2004 | — |
| 0 (this device) | K070729 | Balanceback Mobile Intuitive VNG System | Fall Prevention Technologies, LLC | 2007 | — |
| +1 | K152915 | Eye-Sync | Syncthink, Inc. | 2016 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042529 | Balanceback VNG SystemSummary page 1…I Predicate Devices: Device Name 510(k) Number Ibalanceback- Intuitive VNG System IK042529 Indications for Use: The balancebackTm Mobile iVNG device is intended for recording, viewing, and analyzing eye movements in su… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152915 | Eye-Sync | 2016 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152915 (Syncthink, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K042529.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 balanceback TM Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG 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/K070729 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070729: Balanceback Mobile Intuitive VNG System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070729
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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