# KDN: System, Perfusion, Kidney

- Device class: 2; regulation: 21 CFR 876.5880; FDA's rule: 510(k) required
- FDA decisions: 44
- 510(k) review time 2021–2025: median 235 days (middle half 151–262)
- 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)
- 2016: 1
- 2018: 2
- 2019: 2
- 2020: 2
- 2021: 3
- 2022: 1
- 2023: 2
- 2024: 2
- 2025: 5
- 2026: 3

## Most-cited predicates
- K091245: Costorsol (2009), cited by 6
- K073693: Costorsol (2008), cited by 5
- K091989: Perfadex and Perfadex with Tham (2010), cited by 4
- K021362: Lifeport, Kidney Perfusion Transporter (KTR) (2003), cited by 3
- K192869: SherpaPak Lung Preservation System , SherpaPak Liver Transport System (2020), cited by 3
- K083453: Costorsol (2009), cited by 3
- K972066: Belzer-MPS (1997), cited by 2
- K170826: Perfadex Plus (2018), cited by 2
- K992209: Custodiol (1999), cited by 2
- K133694: Sherpa Pak Transporter (2014), cited by 2

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