510(k) · Cleared
ClearedICS Impulse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics · GWN Nystagmograph
Cleared on Nov 16, 2015 as substantially equivalent to K061791 (Gn Otometrics A/S, 2006) and 1 other predicate after a 165-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- Nov 16, 2015
- Review
- 165 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991497 (1999). 5 ancestors in all, the oldest K891008 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK991497 Ics Medical Chartr Eng/VNG Diagnostic SystemIcs Medical Corp. · 1999
- 1 generation backK061791 Focus VNG/Eng Type 1068Gn Otometrics A/S · 2006
- This deviceK151504 ICS ImpulseGn Otometrics · 2015
- Descendant · cites it directly · 0 of its ownK242198 ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025
- Descendant · cites it directly · 0 of its ownK242726 Synapsys VHITInventis S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK163270 ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991497 | Ics Medical Chartr Eng/VNG Diagnostic System | Ics Medical Corp. | 1999 | — |
| −1 | K061791 | Focus VNG/Eng Type 1068 | Gn Otometrics A/S | 2006 | — |
| 0 (this device) | K151504 | ICS Impulse | Gn Otometrics | 2015 | — |
| +1 | K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025 | — |
| +1 | K242726 | Synapsys VHIT | Inventis S.R.L. | 2025 | — |
| +1 | K163270 | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061791 | Focus VNG/Eng Type 1068Summary page 4…cation Name: Code GWN, Nystagmograph, Regulation 882.1460 Common/Usual Name: Nystagmograph 2. Equivalent legally marketed devices: 510(k) # Name of Device Manufacturer K061791 Type 1068 ICS Chartr 200 VNG | GN Otometrics K122550 ICS Type 1085 Impulse GN Otometrics 3. Description of the Device: The device… | 2006 |
| * | K122550 | Ics ImpulseSummary page 4…1460 Common/Usual Name: Nystagmograph 2. Equivalent legally marketed devices: 510(k) # Name of Device Manufacturer K061791 Type 1068 ICS Chartr 200 VNG | GN Otometrics K122550 ICS Type 1085 Impulse GN Otometrics 3. Description of the Device: The device is a combination of hardware and software. The patie… | 2013 |
What descends from it? (3)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K242198 (Natus Medical Denmark Aps, 2025) has gone furthest, with 0 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. 2015, 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 ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by
measuring, recording, displaying, and analyzing eye and head movements.
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/K151504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151504: ICS Impulse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151504
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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