# BYL: Tent, Oxygen

- Device class: 1; regulation: 21 CFR 868.5700; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1980: 1
- 1982: 1
- 1985: 2
- 1988: 1
- 1989: 3
- 1990: 1
- 1991: 1
- 1994: 1

## Most-cited predicates
- K893713: Nova Oxygen Tent (1989), cited by 1

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