# K960097: Chartr EP

- Pathway: 510(k) (Traditional)
- Applicant: Ics Medical Corp.
- Decided: Feb 21, 1997 after 407 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
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K960097
Methodology: https://510kreport.com/methodology