510(k) · Cleared
ClearedIcs Medical Chartr EP with Assr and Chartr Oae Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ics Medical · EWO Audiometer
Cleared on Jul 24, 2003 as substantially equivalent to K002985 (Ics Medical Corp., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 12 later devices descend from it.
- Decided
- Jul 24, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002985 (2000). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002985 Ics Medical Chartr EP and Chartr Oae SystemsIcs Medical Corp. · 2000
- This deviceK031986 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 · 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
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 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002985 | Ics Medical Chartr EP and Chartr Oae Systems | Ics Medical Corp. | 2000 | — |
| 0 (this device) | 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 |
| +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 | — |
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), 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 EWO? 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 EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K002985 | Ics Medical Chartr EP and Chartr Oae Systems Our reading of the summary gave K002885, FDA’s number for Dade Pfa-100 Platelet Function Analyzer Model-100, Dade… (Dade Behring, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CHARTR EP and CHARTR OAE Systems”. | 2000 |
What descends from it? (12)
See all 122 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?
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CHARTRO EP System is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.
The CHARTRO OAE is indicated for the determination of cochlear function in infants, children, and adults which provides information about hearing without subjective response from the individual being tested.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031986: Ics Medical Chartr EP with Assr and Chartr Oae Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031986
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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