# ERA: Otoscope

- Device class: 1; regulation: 21 CFR 874.4770; FDA's rule: 510(k) exempt
- FDA decisions: 56
- 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)
- 1986: 3
- 1990: 2
- 1991: 3
- 1992: 6
- 1993: 8
- 1994: 7
- 1995: 10
- 1996: 1
- 2011: 1
- 2013: 2

## Most-cited predicates
- K943916: Videotoscope (1994), cited by 2
- K781029: Otoscope, Diag. Models 20100 & 20200 (1978), cited by 1
- K904802: Video Otoscope (1991), cited by 1
- K932503: RI-Mini (1993), cited by 1

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