# EWO: Audiometer

- Device class: 2; regulation: 21 CFR 874.1050; FDA's rule: 510(k) exempt
- FDA decisions: 235
- 510(k) review time 2021–2025: median 164 days (middle half 120–198)
- Recalls: 5 (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)
- 2012: 4
- 2013: 2
- 2014: 1
- 2015: 4
- 2017: 2
- 2018: 2
- 2019: 1
- 2022: 1
- 2023: 1
- 2024: 2

## Most-cited predicates
- K072033: Otodynamics Otoport (2007), cited by 4
- K970279: Race Car Tympanometer with Audiometer (AE-Rcaud I/Quik Tymp 1(AE-Quik 1)/Quick Tymp 2(AE-Quik 2) (1997), cited by 3
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions (2002), cited by 3
- K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe (1998), cited by 3
- K052562: Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems. (2005), cited by 3
- K964132: Modification to Otoacoustic Emissions (OAE0 Test Instrument (1997), cited by 3
- K934658: Gsi 60 Dpoae System (1994), cited by 3
- K010165: Ero Scan Oae Test System (2001), cited by 3
- K133012: Sentiero (2014), cited by 3
- K130795: TITAN (2013), cited by 3

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