# K220139: QScreen

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Aug 3, 2022 after 197 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- 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.

## Indications for use
The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable.

Source page: https://510kreport.com/device/K220139
Methodology: https://510kreport.com/methodology