# BZL: Computer, Oxygen-Uptake

- Device class: 2; regulation: 21 CFR 868.1730; FDA's rule: 510(k) required
- FDA decisions: 33
- 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)
- 1993: 2
- 1994: 2
- 1997: 1
- 2002: 2
- 2003: 1
- 2006: 1
- 2007: 2
- 2010: 1
- 2011: 1
- 2020: 2

## Most-cited predicates
- K021490: Reevue Indirect Calorimeter, Model#8100 (2003), cited by 2
- K922660: Physio-Dyne Easi - Lab (1993), cited by 2
- K061731: Medgraphics Ultima System (2006), cited by 2
- K070858: Express Series (2007), cited by 2
- K912906: Medgraphics PF/DX (1992), cited by 1
- K010577: Bodygem, Model HB211 (2002), cited by 1

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