510(k) · Cleared
ClearedIntegrity V500 (Integrity, Integrity with VEMP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivosonic, Inc. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Dec 19, 2024 as substantially equivalent to K162037 (Interacoustics A/S, 2017) after an 85-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 19, 2024
- Review
- 85 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002985 (2000). 9 ancestors in all, the oldest K960097 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- 5 generations backK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- 4 generations backK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009 · Recalled
- 3 generations backK092373 Ics Chartr EP 200Gn Otometrics · 2009
- 2 generations backK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- 1 generation backK162037 Eclipse with VEMPInteracoustics A/S · 2017
- This deviceK242954 Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| −5 | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae Systems | Ics Medical | 2003 | — |
| −4 | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | 1 |
| −3 | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| −2 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| −1 | K162037 | Eclipse with VEMP | Interacoustics A/S | 2017 | — |
| 0 (this device) | K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 GWJ? 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 GWJ device
- #1 K233649 ALGO Pro Newborn Hearing Screener (ALGO Pro)score 7.6 · 3 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 |
|---|---|---|---|
| * | K162037 | Eclipse with VEMPSummary page 5…882.1900 Product Code Class GWJ 3. PREDICATE DEVICE Predicate Device: Eclipse with VEMP Manufacturer: Interacoustics 510(k) No. K162037 Date Cleared March 23, 2017 4. REFERENCE DEVICE Predicate Device: Integrity, Model V500 M… | 2017 |
| † | K043396 | Integrity, Model V500 | 2005 |
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 24 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242954: Integrity V500 (Integrity, Integrity with VEMP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242954
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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