# K072033: Otodynamics Otoport

- Pathway: 510(k) (Traditional)
- Applicant: Otodynamics, Ltd.
- Decided: Nov 13, 2007 after 112 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: 1 generation back to K983350 (1998). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983350: ILO292 DP Echoport Plus Oae System, Otodynamics, Ltd. (1998) Summary page 1.
- K983352: ILO2088 Enchocheck or ILO2088 Otocheck, Otodynamics, Ltd. (1998) Summary page 1.

## Most influential descendants
- 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
- K112247: A Baer with Abaer I/O Function (2012), 1 descendant of its own
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (2011), 1 descendant of its own
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own
- K240430: Otoport Pro (2024), 0 descendants of its own

## Indications for use
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

Source page: https://510kreport.com/device/K072033
Methodology: https://510kreport.com/methodology