# ETY: Tester, Auditory Impedance

- Device class: 2; regulation: 21 CFR 874.1090; FDA's rule: 510(k) required
- FDA decisions: 70
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2012: 1
- 2014: 1
- 2015: 2
- 2016: 2
- 2017: 1
- 2019: 1

## Most-cited predicates
- K994254: Interacoustics AT235 Impedance Audiometer (2000), cited by 4
- K000097: Gsi 2000 Middle Ear Analyzer (2000), cited by 2
- K910247: Zodiac 901 Middle-Ear Analyzer (1991), cited by 2
- K033645: Otoflex 100 Tye 1012 (2004), cited by 2
- K903066: Amplaid 770 Admittance Meter (1990), cited by 2
- K911095: Gsi 37 Auto Tymp (1991), cited by 2
- K083861: Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite (2009), cited by 2
- K923072: Handtymp (1993), cited by 1
- K905704: MA630 Imped Screener/MA640 Imped/Audiomet Screener (1991), cited by 1
- K955289: Race Car Tympanometer (1995), cited by 1

Source page: https://510kreport.com/product-code/ETY
Data by year (CSV): https://510kreport.com/product-code/ETY.csv