510(k) · Cleared
ClearedNystagram Video Nystagmography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ototronix, LLC · GWN Nystagmograph
Cleared on Apr 26, 2013 as substantially equivalent to K042529 (Fall Prevention Technologies, LLC, 2004) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 26, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K925111 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
View 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) | K130201 | Nystagram Video Nystagmography System | Ototronix, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2008 | 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? (3)
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 2…ially available VNG systems in the market. Specifically the Nystagram TM is substantially equivalent to the following predicate devices: * BalanceBack VNG device (K042529) * GN Otometrics ICS Chartr ENG/VNG System (K991497) * Interacoustics 2D-VOG System (K072254) All four devices hav… | 2004 |
| * | K991497 | Ics Medical Chartr Eng/VNG Diagnostic SystemSummary page 2…Nystagram TM is substantially equivalent to the following predicate devices: * BalanceBack VNG device (K042529) * GN Otometrics ICS Chartr ENG/VNG System (K991497) * Interacoustics 2D-VOG System (K072254) All four devices have the same intended use and use similar technology and comp… | 1999 |
| * | K072254 | VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog SystemSummary page 2…following predicate devices: * BalanceBack VNG device (K042529) * GN Otometrics ICS Chartr ENG/VNG System (K991497) * Interacoustics 2D-VOG System (K072254) All four devices have the same intended use and use similar technology and components. All patient preparation and test protoco… | 2008 |
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 19 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 5 ancestors has a recall.
- 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. 2013, 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 Nystagram TM is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130201: Nystagram Video Nystagmography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130201
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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