# BYT: Ventilator, External Body, Negative Pressure, Adult (Cuirass)

- Device class: 2; regulation: 21 CFR 868.5935; FDA's rule: 510(k) required
- FDA decisions: 21
- 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)
- 1981: 1
- 1983: 1
- 1984: 2
- 1986: 2
- 1988: 2
- 1989: 3
- 1990: 3
- 1991: 2
- 1993: 1
- 2008: 2

## Most-cited predicates
- K924341: Hayek Oscillator (TM) (1993), cited by 1
- K910947: Nev-10 Negative Pressure Ventilator (1991), cited by 1

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