510(k) · Cleared
ClearedEclipse with VEMP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · GWJ Stimulator, Auditory, Evoked Response
Cleared on Mar 23, 2017 as substantially equivalent to K143670 (Gn Otometrics A/S, 2015) and 1 other predicate after a 244-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Mar 23, 2017
- Review
- 244 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002985 (2000). 8 ancestors in all, the oldest K960097 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- 4 generations backK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- 3 generations backK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009 · Recalled
- 2 generations backK092373 Ics Chartr EP 200Gn Otometrics · 2009
- 1 generation backK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- This deviceK162037 Eclipse with VEMPInteracoustics A/S · 2017
- Descendant · cites it directly · 0 of its ownK242954 Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| −4 | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae Systems | Ics Medical | 2003 | — |
| −3 | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | 1 |
| −2 | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| −1 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| 0 (this device) | K162037 | Eclipse with VEMP | Interacoustics A/S | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 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 |
|---|---|---|---|
| * | K143670 | Ics Chartr EP 200 with VempSummary page 4…to 21 CFR 882.1900) Predicate Device 1: Predicate Device ICS CHARTR EP 200 WITH VEMP Manufacturer GN OTOMETRICS A/S7 510(k) No. K143670 Date Cleared 10/23/2015 Predicate Device 2: Predicate Device Eclipse with EP15, EP25 software modules M… | 2015 |
| * | K090406 | EP15 Software Module, EP25 Software ModuleSummary page 4…23/2015 Predicate Device 2: Predicate Device Eclipse with EP15, EP25 software modules Manufacturer Interacoustics A/S 510(k) No. K090406 Date Cleared 07/22/2009 510(k) Summary p. 1 Eclipse with VEMP… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | 2024 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K242954 (Vivosonic, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143670.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162037: Eclipse 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/K162037
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