510(k) · Cleared
ClearedIcs Medical Chartr EP and Chartr Oae Systems
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 Dec 13, 2000 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Dec 13, 2000
- Review
- 79 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- Descendant · cites it directly · 12 of its ownK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K031986Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003 · cites it directly12descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| +1 | 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 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 132 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?
- Of its descendants, K031986 (Ics Medical, 2003) has gone furthest, with 12 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/K002985 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002985: Ics Medical Chartr EP and Chartr Oae Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002985
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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