# CBF: Chamber, Hyperbaric

- Device class: 2; regulation: 21 CFR 868.5470; FDA's rule: 510(k) required
- FDA decisions: 69
- 510(k) review time 2021–2025: median 362 days (middle half 314–409)
- Recalls: 2 (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)
- 2008: 3
- 2009: 1
- 2010: 3
- 2011: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K930748: Sigma MP Multiplace Hyperbaric Chamber (1993), cited by 7
- K950386: Model 3200P/3200PR Hyperbaric Chamber (1995), cited by 6
- K950957: Multiplace Hyperbaric Treatment Chamber System (1995), cited by 5
- K934164: Model 2500E/2500ER Hyperbaric Chamber (1995), cited by 5
- K832127: Nautilus Monoplace Hyperbaric Unit (1983), cited by 4
- K031649: SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities (2003), cited by 4
- K954387: T Class Hyperbaric Facilities (1995), cited by 4
- K862198: Sigma II - Dual Place Hyperbaric Chamber (1986), cited by 4
- K990927: Sigma 3400 Monoplace Hyperbaric Chamber (1999), cited by 3
- K874752: Gamow Hyperbaric Bag (1988), cited by 2

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