# K213345: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Jun 22, 2022 after 257 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902540 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133012: Sentiero, Path Medical GmbH (2014) Summary page 4.

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0401-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0402-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0403-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0404-2024: Affected lots of product may experience technical distortions to a greater extent than expected.

## Indications for use
Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only). Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active patient participation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.

Source page: https://510kreport.com/device/K213345
Methodology: https://510kreport.com/methodology