# FOA: Board, Cardiopulmonary

- Device class: 1; regulation: 21 CFR 880.6080; FDA's rule: 510(k) exempt
- FDA decisions: 3
- 510(k) review time 2021–2025: median 29 days (middle half 29–29)
- Recalls: 0 (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)
- 1981: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- K191689: EleGARD Patient Positioning System (2020), cited by 1

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