# BZO: Set, Tubing And Support, Ventilator (W Harness)

- Device class: 1; regulation: 21 CFR 868.5975; FDA's rule: 510(k) exempt
- FDA decisions: 88
- Recalls: 6 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 7
- 1987: 3
- 1988: 4
- 1989: 4
- 1990: 4
- 1991: 1
- 1992: 2
- 1993: 6
- 1994: 4
- 1995: 7

## Most-cited predicates
- K945740: Infant Flow System (1995), cited by 2
- K841722: Mass Spectrometer Interface (1984), cited by 1

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