510(k) · Cleared
ClearedEyetracker/Ideas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.A. Instrumentation Difra · GWN Nystagmograph
Cleared on Sep 18, 2007 as substantially equivalent to K991497 (Ics Medical Corp., 1999) and 3 other predicates after a 190-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 18, 2007
- Review
- 190 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K964325 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964325 Visualeyes: Video Eye MonitorMicromedical Technologies, Inc. · 1997
- This deviceK070670 Eyetracker/IdeasS.A. Instrumentation Difra · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964325 | Visualeyes: Video Eye Monitor | Micromedical Technologies, Inc. | 1997 | — |
| 0 (this device) | K070670 | Eyetracker/Ideas | S.A. Instrumentation Difra | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991497 | Ics Medical Chartr Eng/VNG Diagnostic SystemSummary page 2…mcl il, , 1(1I rfl10 *w di; bh Substantial Equivalency: The device is substantially equivalent to: **the CHARTR ENG!VNG Diagnostic System (K99 1497) marketed by ICS Medical Corporation *.the ENGPLUS (K010059) marketed by WesternSystem Research,lInc. the V… | 1999 |
| * | K010059 | EngplusSummary page 2…ency: The device is substantially equivalent to: **the CHARTR ENG!VNG Diagnostic System (K99 1497) marketed by ICS Medical Corporation *.the ENGPLUS (K010059) marketed by WesternSystem Research,lInc. the VISUAL EYES (K964325) marketed by Micromedical Technologies, Inc. For its a… | 2001 |
| * | K964325 | Visualeyes: Video Eye MonitorSummary page 2…Diagnostic System (K99 1497) marketed by ICS Medical Corporation *.the ENGPLUS (K010059) marketed by WesternSystem Research,lInc. the VISUAL EYES (K964325) marketed by Micromedical Technologies, Inc. For its ability to record torsional movements, the device is substantially equivalen… | 1997 |
| * | K982103 | Ulmer (VNG) Video NystagmographSummary page 2…by Micromedical Technologies, Inc. For its ability to record torsional movements, the device is substantially equivalent to: **the ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982 103) marketed by Synapsys, Inc. **the I-PORTAL, also known as I-PORTAL VNG, part of the NEURO- OTOLOGIC TEST CE… | 1998 |
| Kept off the family tree | K781268 | FDA’s K781268 is Chair, Vestibular, Rotary, Comput. Our OCR of the scanned summary read K781268, FDA’s number for Chair, Vestibular, Rotary, Comput. (Contraves). Its FDA name has none of the distinctive words the summary uses for the device it names, “I-PORTAL, also known as I-PORTAL VNG, part of the NEURO-OTOLOGIC…”. Kept off the family tree. Summary page 2…VNG) VIDEO NYSTAGMOGRAPH (K982 103) marketed by Synapsys, Inc. **the I-PORTAL, also known as I-PORTAL VNG, part of the NEURO- OTOLOGIC TEST CENTER (K78 1268) marketed by Neuro Kinetics, Inc. Description of the device: The device is a PC-based system for measuring, recording and displa… | 1978 |
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?
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K991497.
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 device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.
The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070670: Eyetracker/Ideas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070670
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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