510(k) · Cleared
ClearedIcs Medical Chartr Eng/VNG Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ics Medical Corp. · GWN Nystagmograph
Cleared on Jul 28, 1999 after a 90-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jul 28, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK991497 Ics Medical Chartr Eng/VNG Diagnostic SystemIcs Medical Corp. · 1999
- Descendant · cites it directly · 4 of its ownK061791 Focus VNG/Eng Type 1068Gn Otometrics A/S · 2006
- Descendant · 2 generations on · 3 of its ownK151504 ICS ImpulseGn Otometrics · 2015
- Descendant · cites it directly · 1 of its ownK050098 Ddat OmtDdat (Uk), Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK242198 ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025
- Descendant · 3 generations on · 0 of its ownK242726 Synapsys VHITInventis S.R.L. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K061791Focus VNG/Eng Type 1068Gn Otometrics A/S · 2006 · cites it directly4descendants
- K151504ICS ImpulseGn Otometrics · 2015 · 2 generations on3descendants
- K050098Ddat OmtDdat (Uk), Ltd. · 2005 · cites it directly1descendant
- K242198ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025 · 3 generations on0descendants
- K242726Synapsys VHITInventis S.R.L. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991497 | Ics Medical Chartr Eng/VNG Diagnostic System | Ics Medical Corp. | 1999 | — |
| +1 | K061791 | Focus VNG/Eng Type 1068 | Gn Otometrics A/S | 2006 | — |
| +2 | K151504 | ICS Impulse | Gn Otometrics | 2015 | — |
| +1 | K050098 | Ddat Omt | Ddat (Uk), Ltd. | 2005 | — |
| +3 | K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025 | — |
| +3 | K242726 | Synapsys VHIT | Inventis S.R.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | — | 2D VOG-VIDEO-OCULOGRAPHY device Named without a submission number | |
| * | — | Chartr® Eng System Named without a submission number |
What descends from it? (10)
5 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?
- Of its descendants, K061791 (Gn Otometrics A/S, 2006) has gone furthest, with 4 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.
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?
This device is used to observe, record and measure eye movements in
patients during testing of vestibular function.
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/K991497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991497: Ics Medical Chartr Eng/VNG Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991497
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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