# K083399: Ics Chartr EP 200

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: Feb 20, 2009 after 95 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002985 (2000). 3 ancestors in all.
11 later devices descend from it; 1 cites 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)
- K960097: Chartr EP, Ics Medical Corp. (1997) Summary page 1.
- K002985: Ics Medical Chartr EP and Chartr Oae Systems, Ics Medical Corp. (2000) Summary page 1.
- K031986: Ics Medical Chartr EP with Assr and Chartr Oae Systems, Ics Medical (2003) Summary page 1.

## Most influential descendants
- K092373: Ics Chartr EP 200 (2009), 10 descendants of its own
- 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

## Recalls of this device
- May 28, 2019 · Class II · Z-0170-2020: There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

## Indications for use
The Chartr EP 200 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/K083399
Methodology: https://510kreport.com/methodology