# K012415: Auris Aep

- Pathway: 510(k) (Traditional)
- Applicant: Synapsys, Inc.
- Decided: Dec 18, 2001 after 141 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AURIS I and AURIS 1 ABR Systems provide information regarding the functional integrity of the. - peripheral and central auditory system. ft tests for auditory .evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is imended for use.in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.

Source page: https://510kreport.com/device/K012415
Methodology: https://510kreport.com/methodology