# BYS: Oxygenator, Long Term Support Greater Than 6 Hours

- Device class: 2; regulation: 21 CFR 870.4100; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 23 days (middle half 23–23)
- 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)
- 1977: 1
- 2020: 1
- 2023: 1

## Most-cited predicates
- K191935: Nautilus Smart ECMO Module (2020), cited by 1

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