# K173567: Sera

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Feb 14, 2018 after 86 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: 4 generations back to K060539 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171506: Easyscreen, Maico Diagnostics GmbH (2017) Summary page 4.

## Indications for use
The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages. The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages. The Sera™ with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Sera with ABRIS is newborns. The Sera™ System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

Source page: https://510kreport.com/device/K173567
Methodology: https://510kreport.com/methodology