# MJV: Device, Inflation, Middle Ear

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 82 days (middle half 70–93)
- 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)
- 1992: 1
- 1995: 1
- 2008: 1
- 2021: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K951596: Earclear (1995), cited by 1
- K230502: Ear Pressure Relief Device (Model:ER813B) (2023), cited by 1
- K920840: Otovent (1992), cited by 1
- K203754: Eustachi Ear Pressure Relief Device (2021), cited by 1
- K073401: Earpopper, Model EP-2000, EP-2100, EP-3000 (2008), cited by 1

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