# NEA: Cement, Ear, Nose And Throat

- Device class: 2; regulation: 21 CFR 872.3275; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 2001: 2
- 2004: 1
- 2006: 1
- 2008: 1
- 2014: 1

## Most-cited predicates
- K042516: Otomimix (2004), cited by 3
- K003567: Serenocem, Model BC 010 (2001), cited by 2
- K011338: Oto-Cem (2001), cited by 2
- K080032: Envoycem, Model 1640 (2008), cited by 1

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