# K031051: Smartep-Assr, Model M811007

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Feb 20, 2004 after 324 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: 4 generations back to K930328 (1993). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021895: Bio-Logic Master Evoked Response System, Bio-Logic Systems Corp. (2002) Summary page 1.

## Most influential descendants
- K061443: Smart Usblite, Model M011120 (2006), 1 descendant of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own
- K090579: Smartscreener-PLUS2 (2009), 0 descendants of its own

## Indications for use
The intended use of the SmartEP-ASSR product is for the recording of auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds. SmartEP-ASSR can be used for patients of all ages. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Source page: https://510kreport.com/device/K031051
Methodology: https://510kreport.com/methodology