# K981142: Maico MA53

- Pathway: 510(k) (Traditional)
- Applicant: Bernafon-Maico, Inc.
- Decided: Apr 22, 1998 after 23 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
The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss

Source page: https://510kreport.com/device/K981142
Methodology: https://510kreport.com/methodology