# K031713: Audiometer, Otoacoustic Emission, Auditory Branstem Response Access

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare, Inc.
- Decided: Aug 12, 2003 after 71 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: 2 generations back to K902540 (1990). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K024205: Audioscreener Oae+Abr, Everest Biomedical Instruments Co. (2003)
- K974237: Gsi 70 Audiopath Screener, Grason-Stadler, Inc. (1998) Summary page 1.
- K934658: Gsi 60 Dpoae System, Lucas Grason-Stadler, Inc. (1994) Summary page 1.
- K911095: Gsi 37 Auto Tymp, Lucas Grason-Stadler, Inc. (1991) Summary page 1.
- K902540: Gsi 17 Screening Audiometer, Grason-Stadler, Inc. (1990) Summary page 1.

## Most influential descendants
- K073384: Smart Coupler, Model M015401 (2008), 0 descendants of its own

## Indications for use
The Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.

Source page: https://510kreport.com/device/K031713
Methodology: https://510kreport.com/methodology