# K011135: Gsi Audera

- Pathway: 510(k) (Traditional)
- Applicant: Nicolet Biomedical
- Decided: Jul 26, 2001 after 104 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K141524: Neuro-Audio (2015), 0 descendants of its own

## Recalls of this device
- Sep 16, 2008 · Not classified · Z-0195-2009: GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera uni

Source page: https://510kreport.com/device/K011135
Methodology: https://510kreport.com/methodology