# K092089: Clarujust

- Pathway: 510(k) (Traditional)
- Applicant: Audigence, Inc.
- Decided: Mar 10, 2010 after 244 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clarujust is an automated testing software accessory for ANSI S3.6 speech audiometers. Clarujust is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. This device is intended to be used by trained medical professional for patients over 18 without cognitive difficulties.

Source page: https://510kreport.com/device/K092089
Methodology: https://510kreport.com/methodology