# ECX: Cylinder, Compressed Gas, And Valve

- Device class: 1; regulation: 21 CFR 868.2700; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 18 (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)
- 1977: 1
- 2004: 1
- 2006: 2
- 2007: 1
- 2011: 1
- 2014: 2
- 2015: 2
- 2016: 2
- 2017: 1

## Most-cited predicates
- K033897: Medicyl-E-Lite Portable Oxygen Delivery System (2004), cited by 3
- K053117: EZ-OX Plus (2006), cited by 3
- K063354: Linde Integrated Valve (Liv) (2007), cited by 2
- K101792: Liv Linde Intergrated Valve-Portable Oxygen System, Model M706 (2011), cited by 2
- K131386: EZ-OX Plus Generation II (2014), cited by 1
- K143060: Intelli-Ox (2015), cited by 1
- K132778: Grab 'N GO Plus, Grab 'N GO Digital (2014), cited by 1

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