# K130795: TITAN

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Jun 20, 2013 after 90 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
Longest line of descent: 2 generations back to K060539 (2006). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103760: TITAN, Interacoustics A/S (2011) Summary page 1.
- K052562: Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems., Interacoustics AS (2005) Summary page 1.

## Most influential descendants
- K171506: Easyscreen (2017), 1 descendant of its own
- K191372: Lyra (2019), 0 descendants of its own
- K173567: Sera (2018), 0 descendants of its own
- K172403: GSI Novus (2017), 0 descendants of its own

## Indications for use
The Titan with TEOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440 includes all ages.

Source page: https://510kreport.com/device/K130795
Methodology: https://510kreport.com/methodology