# K082035: Maico MB 11 with Beraphone Probe

- Pathway: 510(k) (Traditional)
- Applicant: Maico Diagnostics
- Decided: Jan 29, 2009 after 196 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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.

## Most influential descendants
- K103760: TITAN (2011), 5 descendants of its own
- K130795: TITAN (2013), 4 descendants of its own
- K171506: Easyscreen (2017), 1 descendant of its own
- K191372: Lyra (2019), 0 descendants of its own
- K173567: Sera (2018), 0 descendants of its own

## Indications for use
The Maico MB 11 with BERAphone and the MB 11 Standard are intended to generate evoked auditory brainstem response (ABR) - based measurements for newborn hearing screening, providing a PASS/REFER result. This does not require special technical skills or interpretation of the results.

Source page: https://510kreport.com/device/K082035
Methodology: https://510kreport.com/methodology