# K092373: Ics Chartr EP 200

- Pathway: 510(k) (Special)
- Applicant: Gn Otometrics
- Decided: Sep 3, 2009 after 29 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002985 (2000). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031986: Ics Medical Chartr EP with Assr and Chartr Oae Systems, Ics Medical (2003) Summary page 1.
- K083399: Ics Chartr EP 200, Gn Otometrics A/S (2009) Summary page 1.

## Most influential descendants
- K143670: Ics Chartr EP 200 with Vemp (2015), 4 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own
- K163326: SmartEP (2017), 1 descendant of its own
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K162037: Eclipse with VEMP (2017), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K092373
Methodology: https://510kreport.com/methodology