# K904926: Smart-EP

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Aug 2, 1991 after 275 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.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K070608: Smartep, Model M010000 (2007), 16 descendants of its own
- K123843: Neuroepg System (2013), 12 descendants of its own
- K132616: EPAD (2014), 11 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own

Source page: https://510kreport.com/device/K904926
Methodology: https://510kreport.com/methodology