# K031986: Ics Medical Chartr EP with Assr and Chartr Oae Systems

- Pathway: 510(k) (Special)
- Applicant: Ics Medical
- Decided: Jul 24, 2003 after 27 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002985 (2000). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002985: Ics Medical Chartr EP and Chartr Oae Systems, Ics Medical Corp. (2000). 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”.

## Most influential descendants
- K083399: Ics Chartr EP 200 (2009), 11 descendants of its own
- 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

## Indications for use
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.

Source page: https://510kreport.com/device/K031986
Methodology: https://510kreport.com/methodology