# CAW: Generator, Oxygen, Portable

- Device class: 2; regulation: 21 CFR 868.5440; FDA's rule: 510(k) required
- FDA decisions: 289
- 510(k) review time 2021–2025: median 221 days (middle half 169–291)
- Recalls: 28 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 3
- 2019: 2
- 2020: 5
- 2021: 2
- 2022: 4
- 2023: 8
- 2024: 2
- 2025: 12
- 2026: 6

## Most-cited predicates
- K013931: Omni Oxygen System, Model 1000 (2002), cited by 10
- K230052: Inogen Rove 6 (2023), cited by 8
- K003939: Venture Home Fill II, Model Ioh 200 (2001), cited by 6
- K020324: Lifestyle Oxygen Concentrator (2002), cited by 5
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02 (2002), cited by 5
- K020330: Deployable Oxygen Concentration System (Docs) (2002), cited by 5
- K061261: L4 Oxygen Concentrator (2006), cited by 5
- K210371: Portable Oxygen Concentrator, model: P2-E6 (2022), cited by 4
- K955549: Oxlife Oxygen Concentrators (1996), cited by 4
- K071608: A&J POCA01 Oxygen Concentrator (2008), cited by 4

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