# K001058: Audioscreener Oae + Abr

- Pathway: 510(k) (Traditional)
- Applicant: Kedly, Inc.
- Decided: Jun 2, 2000 after 60 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K024205: Audioscreener Oae+Abr (2003), 5 descendants of its own
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (2015), 2 descendants of its own
- K031713: Audiometer, Otoacoustic Emission, Auditory Branstem Response Access (2003), 1 descendant of its own
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own
- K240430: Otoport Pro (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K001058
Methodology: https://510kreport.com/methodology