Interacoustics Sera Audiometer – Class II Diagnostic Device

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK173567	Date14 Feb 2018Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K173567

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Sera

510(k) Number: K173567
FDA product code: EWO

Device class: Class II
Regulation: 21 CFR Part 874.1050
Advisory committee: Ear, Nose, Throat
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Easyscreen K171506 29 Aug 2017 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sera is a Class II audiometer, a diagnostic device designed to measure hearing thresholds and assess auditory function. It employs pure-tone air and bone conduction testing, speech audiometry, and impedance measurements to evaluate hearing sensitivity across different frequencies and pathways. The device is intended for clinical use in otolaryngology and audiology settings to aid in the diagnosis and management of hearing disorders.

The Sera audiometer is supplied as a reusable, non-sterile medical device intended for use in clinical environments such as hospitals, audiology clinics, and ENT (ear, nose, and throat) practices. It operates within standard electrical safety parameters and is not classified as MRI-safe or MRI-conditional. The device is regulated under FDA 510(k) clearance (K173567) and adheres to regulatory requirements outlined in 21 CFR 874.1050. It is distributed with accompanying software and calibration tools, requiring periodic maintenance as specified in the manufacturer’s instructions.

Devices cleared under K173567

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K173567
		UDI-DI	Size and differences
Interacoustics Sera Interacoustics A/S	Sera	05711117244540	—	On the market
Interacoustics Sera Interacoustics A/S	Sera	05711117190823	—	On the market

Similar devices

Other devices filed under FDA product code EWO (Audiometer).

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