# K934658: Gsi 60 Dpoae System

- Pathway: 510(k) (Traditional)
- Applicant: Lucas Grason-Stadler, Inc.
- Decided: Feb 1, 1994 after 126 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 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
- K974237: Gsi 70 Audiopath Screener (1998), 18 descendants of its own
- K982642: Echo-Screen (1998), 15 descendants of its own
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), 14 descendants of its own
- K122067: Type 1077 Accuscreen (2012), 9 descendants of its own
- K061744: Cochlea-Scan / Cochlea-Scan Plus (2006), 5 descendants of its own

Source page: https://510kreport.com/device/K934658
Methodology: https://510kreport.com/methodology