# FEW: Catheter, Malecot

- Device class: 2; regulation: 21 CFR 876.5090; 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)
- 1992: 1
- 1995: 1
- 1996: 1
- 1998: 1
- 2007: 1
- 2014: 1

## Most-cited predicates
- K140085: Universa Percultaneous  Drainage Catheter (2014), cited by 5
- K070879: Bard Malecot and Pezzer Drains (2007), cited by 2
- K954147: Manan Malecot Basket Drainage Catheter (1996), cited by 1

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