# KCN: Ear Wick

- Device class: 1; regulation: 21 CFR 874.5220; FDA's rule: 510(k) exempt
- FDA decisions: 4
- 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)
- 1979: 1
- 1993: 1
- 1997: 1
- 2006: 1

## Most-cited predicates
- K973578: Invotec Ear Tampon (Wick) W/String (1997), cited by 2

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