510(k) · Cleared
ClearedIcs Chartr EP 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics · GWJ Stimulator, Auditory, Evoked Response
Cleared on Sep 3, 2009 as substantially equivalent to K031986 (Ics Medical, 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002985 (2000). 4 ancestors in all, the oldest K960097 (1997). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- 2 generations backK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- 1 generation backK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009 · Recalled
- This deviceK092373 Ics Chartr EP 200Gn Otometrics · 2009
- Descendant · cites it directly · 4 of its ownK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- Descendant · cites it directly · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK163326 SmartEPIntelligent Hearing Systems · 2017
- Descendant · 2 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK162037 Eclipse with VEMPInteracoustics A/S · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143670Ics Chartr EP 200 with VempGn Otometrics A/S · 2015 · cites it directly4descendants
- K133012SentieroPath Medical GmbH · 2014 · cites it directly4descendants
- K163326SmartEPIntelligent Hearing Systems · 2017 · 2 generations on1descendant
- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 2 generations on1descendant
- K162037Eclipse with VEMPInteracoustics A/S · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| −2 | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae Systems | Ics Medical | 2003 | — |
| −1 | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | 1 |
| 0 (this device) | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| +1 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| +1 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K163326 | SmartEP | Intelligent Hearing Systems | 2017 | — |
| +2 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| +2 | K162037 | Eclipse with VEMP | Interacoustics A/S | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae SystemsSummary page 1…00 Classification name: Stimulator, Auditory, Evoked Response Predicate devices The GN Otometrics ICS CHARTR EP 200 is similar to these relevant Chartr products: K031986, ICS Medical Chartr EP with ASSR and Chartr OAE System Product Code: EWO Regulation Number: 882.1050 K083399, ICS CHARTR EP 200… | 2003 |
| * | K083399 | Ics Chartr EP 200Summary page 1…CHARTR EP 200 is similar to these relevant Chartr products: K031986, ICS Medical Chartr EP with ASSR and Chartr OAE System Product Code: EWO Regulation Number: 882.1050 K083399, ICS CHARTR EP 200 Product Code: GWJ Regulation Number: 882.1900 (without ASSR and Chartr OAE System) The modified ICS CHARTR EP… | 2009 |
What descends from it? (10)
2 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 9 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K143670 (Gn Otometrics A/S, 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K031986.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ICS Chartr EP 200 System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092373: Ics Chartr EP 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092373
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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