# BYX: Tubing, Pressure And Accessories

- Device class: 1; regulation: 21 CFR 868.5860; FDA's rule: 510(k) exempt
- FDA decisions: 62
- Recalls: 1 (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)
- 1984: 2
- 1985: 3
- 1986: 2
- 1990: 7
- 1991: 2
- 1992: 2
- 1993: 2
- 1994: 2
- 1996: 1
- 2001: 1

## Most-cited predicates

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