# K063452: MA 55 Maestro

- Pathway: 510(k) (Traditional)
- Applicant: Maico Diagnostics (Diagnostic Group, LLC)
- Decided: Mar 29, 2007 after 134 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 MA55 system is intended to be used for the detection and diagnosis of suspected hearing loss. (Other module functions may be added to this platform in the future, each module will be re-applied for at that time.)

Source page: https://510kreport.com/device/K063452
Methodology: https://510kreport.com/methodology