# K033645: Otoflex 100 Tye 1012

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics A/S
- Decided: Mar 31, 2004 after 132 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 K910247 (1991). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910247: Zodiac 901 Middle-Ear Analyzer, Madsen Electronics (Canada), Ltd. (1991) Summary page 1.
- K923072: Handtymp, Life-Tech Intl., Inc. (1993) Summary page 1.
- K000097: Gsi 2000 Middle Ear Analyzer, Grason-Stadler, Inc. (2000) Summary page 1.

## Most influential descendants
- K061104: Speechlink 100 Type 1053 (2006), 1 descendant of its own
- K161707: Madsen Zodiac (2016), 0 descendants of its own
- K110286: GN Otometrics Type 1053 Freefit (2011), 0 descendants of its own

## Indications for use
The OTOflex 100 type 1012 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/K033645
Methodology: https://510kreport.com/methodology