# ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

- Device class: 2; regulation: 21 CFR 874.3310; FDA's rule: 510(k) exempt
- FDA decisions: 46
- Recalls: 0 (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)
- 1998: 1
- 2001: 1
- 2002: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2009: 1
- 2011: 1
- 2012: 2

## Most-cited predicates
- K071462: Unity 2 Hia & Probe ( for Use with Unity 2) (2007), cited by 1
- K012306: Audioscan Verifit, Model VF-1 (2001), cited by 1
- K872242: Type 6400 Real Ear Hearing Aid Analyzer (1987), cited by 1
- K884046: Audioscan (TM) Real Ear Measurement System RM500 (1989), cited by 1
- K113831: Primus Hearing Instrument Test Unit (2012), cited by 1
- K061104: Speechlink 100 Type 1053 (2006), cited by 1

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