510(k) · Cleared
ClearedICS Dizcovery (1091)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Denmark Aps · GWN Nystagmograph
Cleared on Feb 14, 2025 as substantially equivalent to K151504 (Gn Otometrics, 2015) after a 203-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Feb 14, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- GWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991497 (1999). 6 ancestors in all, the oldest K891008 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK991497 Ics Medical Chartr Eng/VNG Diagnostic SystemIcs Medical Corp. · 1999
- 2 generations backK061791 Focus VNG/Eng Type 1068Gn Otometrics A/S · 2006
- 1 generation backK151504 ICS ImpulseGn Otometrics · 2015
- This deviceK242198 ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991497 | Ics Medical Chartr Eng/VNG Diagnostic System | Ics Medical Corp. | 1999 | — |
| −2 | K061791 | Focus VNG/Eng Type 1068 | Gn Otometrics A/S | 2006 | — |
| −1 | K151504 | ICS Impulse | Gn Otometrics | 2015 | — |
| 0 (this device) | K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K151504 | ICS ImpulseSummary page 6…tagmograph Regulation Number: 21CFR882.1460 Classification Name: Nystagmograph Product code: GWN Device Class: II Predicate Device: ICS Impulse 510(k) number: K151504 Natus Medical Incorporated | natus.com… | 2015 |
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 26 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K151504.
How does its category compare?
All GWN devicesGWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
ICS Dizcovery is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements. The 1091 ICS Dizcovery is used in the assessment of patients with complaints of a vestibular nature such as dizziness, disequilibrium, and vertigo. The ICS Dizcovery type 1091 does not treat or diagnose the patient; the diagnosis is determined by the credentialed physician. ICS Dizcovery…
Read the full statement (166 words)
ICS Dizcovery is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.
The 1091 ICS Dizcovery is used in the assessment of patients with complaints of a vestibular nature such as dizziness, disequilibrium, and vertigo. The ICS Dizcovery type 1091 does not treat or diagnose the patient; the diagnosis is determined by the credentialed physician.
ICS Dizcovery system is intended to be used by qualified medical personnel. Typical device users are Neurologists, Ears, Nose, and Throat specialists (ENTs), Audiologists, Physical Therapists, and Technicians supervised by one of the four mentioned typical users. Professionals with knowledge of diagnosing balance disorders. Users are assumed to have prior knowledge of the medical and scientific facts underlying the procedures offered by the ICS Dizcovery system.
The intended patient population are children in the age of 10 to 18 and adults in age range from 18 to 99 years with a complaint of dizziness, balance disorder, or vestibular disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242198: ICS Dizcovery (1091).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242198
Report an extraction error
Are you the manufacturer?
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