# NFB: Conserver, Oxygen

- Device class: 2; regulation: 21 CFR 868.5905; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 195 days (middle half 183–242)
- Recalls: 3 (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)
- 2006: 2
- 2007: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2013: 1
- 2016: 1
- 2020: 1
- 2022: 2
- 2025: 1

## Most-cited predicates
- K852650: Oxymatictm Electronic Oxgyen Conserver (1985), cited by 5
- K003455: Modification to Chad Therapeutics Oxymatic Model 401 (2000), cited by 4
- K020329: Devilbiss PD1000 (2002), cited by 3
- K010747: Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830 (2001), cited by 3
- K031983: Inovo, Inc, Economizer Conserving Regulator (2003), cited by 3
- K953852: Model Ipd Oxygen Conserving Device (1995), cited by 3
- K020475: Chad Therapeutics Oxypenumatic Cypress Model 511 (2002), cited by 2
- K090421: Model 350G Gas Conserver (2009), cited by 2
- K961126: Pulse Dose Series (1996), cited by 2
- K992659: O2N Demand-II, Victor Model Ocpr-II (1999), cited by 2

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