# KPJ: Chamber, Oxygen, Topical, Extremity

- Device class: 2; regulation: 21 CFR 878.5650; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 336 days (middle half 191–480)
- 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)
- 2001: 1
- 2002: 2
- 2003: 1
- 2005: 1
- 2008: 1
- 2009: 1
- 2012: 2
- 2019: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K023456: Oxybox System (2003), cited by 3
- K971507: O2 BOOT (1997), cited by 3
- K920948: Topical Sacral Hyperbaric Oxygen Chamber (1992), cited by 3
- K022028: VX-400 Topical Hyperbaric Oxygen Chamber (2002), cited by 2
- K840817: Disposable, Hyperbaric Oxygen Chamber (1984), cited by 1
- K080966: Hyper-Box Topical Wound Oxygen System (2008), cited by 1
- K212121: VHT-200 Wound Treatment System (2023), cited by 1
- K861593: Topical Hyperbaric Oxygen Chamber (1986), cited by 1
- K020466: HEC 1000 (2002), cited by 1
- K831825: Dispos. Hyperbaric Oxygen Cush/Traum (1983), cited by 1

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