# K083861: Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics AS
- Decided: Apr 9, 2009 after 106 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994254 (2000). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994254: Interacoustics AT235 Impedance Audiometer, International Distributors of Electronics For Medi (2000) Summary page 2.

## Most influential descendants
- K133012: Sentiero (2014), 4 descendants of its own
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K220139: QScreen (2022), 0 descendants of its own
- K213345: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (2022), 0 descendants of its own
- K183201: Hearing Healthcare Pro (2019), 0 descendants of its own

## Indications for use
The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.

Source page: https://510kreport.com/device/K083861
Methodology: https://510kreport.com/methodology