510(k) · Cleared
Recalled · Class II · 2019Ics Chartr EP 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics A/S · GWJ Stimulator, Auditory, Evoked Response
Cleared on Feb 20, 2009 as substantially equivalent to K960097 (Ics Medical Corp., 1997) and 2 other predicates after a 95-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it. It has been recalled once.
- Decided
- Feb 20, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002985 (2000). 3 ancestors in all, the oldest K960097 (1997). 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- 1 generation backK031986 Ics Medical Chartr EP with Assr and Chartr Oae SystemsIcs Medical · 2003
- This deviceK083399 Ics Chartr EP 200Gn Otometrics A/S · 2009
- Descendant · cites it directly · 10 of its ownK092373 Ics Chartr EP 200Gn Otometrics · 2009
- Descendant · 2 generations on · 4 of its ownK143670 Ics Chartr EP 200 with VempGn Otometrics A/S · 2015
- Descendant · 2 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK163326 SmartEPIntelligent Hearing Systems · 2017
- Descendant · 3 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K092373Ics Chartr EP 200Gn Otometrics · 2009 · cites it directly10descendants
- K143670Ics Chartr EP 200 with VempGn Otometrics A/S · 2015 · 2 generations on4descendants
- K133012SentieroPath Medical GmbH · 2014 · 2 generations on4descendants
- K163326SmartEPIntelligent Hearing Systems · 2017 · 3 generations on1descendant
- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K083399 | Ics Chartr EP 200 | Gn Otometrics A/S | 2009 | — |
| +1 | K092373 | Ics Chartr EP 200 | Gn Otometrics | 2009 | — |
| +2 | K143670 | Ics Chartr EP 200 with Vemp | Gn Otometrics A/S | 2015 | — |
| +2 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +3 | K163326 | SmartEP | Intelligent Hearing Systems | 2017 | — |
| +3 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 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 |
|---|---|---|
| 2009 | 1 | 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), 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? (3)
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 |
|---|---|---|---|
| * | K960097 | Chartr EPSummary page 1…ator, Auditory, Evoked Response Predicate devices The GN Otometrics ICS CHARTR EP 200 is similar to these relevant Chartr products: ICS Medical Chartr EP system (K960097) Product Code: GWJ Regulation Number: 882.1900 Released: February 2l1st, 1997 ICS Medical Chartr EP and OAE System (… | 1997 |
| * | K002985 | Ics Medical Chartr EP and Chartr Oae SystemsSummary page 1…ICS Medical Chartr EP system (K960097) Product Code: GWJ Regulation Number: 882.1900 Released: February 2l1st, 1997 ICS Medical Chartr EP and OAE System (K002985) Product Code: GWJ &.EWO Regulation Number: 882.1900 Released: December 13th 2000 ICS Medical Chartr EP with ASSR an… | 2000 |
| * | K031986 | Ics Medical Chartr EP with Assr and Chartr Oae SystemsSummary page 1…85) Product Code: GWJ &.EWO Regulation Number: 882.1900 Released: December 13th 2000 ICS Medical Chartr EP with ASSR and Chartr OAE System 510O(K) Number: K03 1986 Product Code: EWO Regulation Number: 882.1050 Released: July 24 ,h2003 ICS CHARTR EP 200 differs from the above in t… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092373 | Ics Chartr EP 200 | 2009 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2019 | Class II | Z-0170-2020 | Device Design | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092373 (Gn Otometrics, 2009) has gone furthest, with 10 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. 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 Chartr EP 200 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/K083399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083399: Ics Chartr EP 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083399
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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