# BYJ: Unit, Liquid-Oxygen, Portable

- Device class: 2; regulation: 21 CFR 868.5655; FDA's rule: 510(k) required
- FDA decisions: 55
- Recalls: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2001: 1
- 2004: 3
- 2005: 2
- 2007: 2
- 2008: 3
- 2010: 1
- 2011: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K993220: Puritan-Bennett Helios Portable Liquid Oxygen System (1999), cited by 4
- K033000: Next Generation Portable Therapeutic Liquid Oxygen System (2004), cited by 3
- K013251: Spirit 300 (2001), cited by 3
- K041122: Precision Liquid Oxygen System (2004), cited by 3
- K833994: Pulsair I & II (1983), cited by 2
- K050153: Spirit, Model Has (2005), cited by 1
- K050414: PLIX (2005), cited by 1
- K071581: Backpack Medical Oxygen System (2007), cited by 1
- K880183: Portable Therapeutic Liquid Oxygen Unit (1988), cited by 1
- K072723: Respironics Golox (2008), cited by 1

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