510(k) · Cleared
ClearedChartr EP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ics Medical Corp. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Feb 21, 1997 after a 407-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 21, 1997
- Review
- 407 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK960097 Chartr EPIcs Medical Corp. · 1997
- Descendant · cites it directly · 11 of its ownK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK092373 Ics Chartr EP 200Gn Otometrics · 2009
- Descendant · 3 generations on · 4 of its ownK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- Descendant · 3 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 4 generations on · 1 of its ownK163326 SmartEPIntelligent Hearing Systems · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K083399Ics Chartr EP 200Gn Otometrics A/S · 2009 · cites it directly11descendants
- K092373Ics Chartr EP 200Gn Otometrics · 2009 · 2 generations on10descendants
- K143670Ics Chartr EP 200 with VempGn Otometrics A/S · 2015 · 3 generations on4descendants
- K133012SentieroPath Medical GmbH · 2014 · 3 generations on4descendants
- K163326SmartEPIntelligent Hearing Systems · 2017 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960097 | Chartr EP | Ics Medical Corp. | 1997 | — |
| +1 | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | 1 |
| +2 | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| +3 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| +3 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +4 | K163326 | SmartEP | Intelligent Hearing Systems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 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), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083399 | Ics Chartr EP 200 | 2009 | 11 |
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?
- Of its descendants, K083399 (Gn Otometrics A/S, 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K960097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960097: Chartr EP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960097
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026