# K010165: Ero Scan Oae Test System

- Pathway: 510(k) (Traditional)
- Applicant: Etymotic Research
- Decided: Mar 12, 2001 after 53 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K150491: ER36 Series OAE Test System (2015), 1 descendant of its own
- K180287: GSI Corti (2018), 0 descendants of its own
- K112733: ER35 Ero-Scan Pro Hearing Test System (2011), 0 descendants of its own
- K070880: ER35 Ero-Scan Pro Hearing Test System (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K010165
Methodology: https://510kreport.com/methodology