# K161707: Madsen Zodiac

- Pathway: 510(k) (Special)
- Applicant: Gn Otometrics
- Decided: Sep 1, 2016 after 72 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: 2 generations back to K910247 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033645: Otoflex 100 Tye 1012, Gn Otometrics A/S (2004) Summary page 4.

## Indications for use
The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.

Source page: https://510kreport.com/device/K161707
Methodology: https://510kreport.com/methodology