# KDL: Set, Perfusion, Kidney, Disposable

- Device class: 2; regulation: 21 CFR 876.5880; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 110 days (middle half 32–208)
- 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)
- 1997: 1
- 2003: 1
- 2005: 1
- 2010: 1
- 2013: 2
- 2017: 1
- 2020: 1
- 2021: 1
- 2022: 2
- 2025: 1

## Most-cited predicates
- K944866: Viaspan (Belzer UW - CSS) (1996), cited by 6
- K043461: Custodiol (2005), cited by 3
- K121736: Perf-Gen Pulsatile Perfusion Solution (2013), cited by 2
- K091656: SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L (2010), cited by 1
- K121618: Bel-Gen Cold Storage Solution (2013), cited by 1
- K883782: Belzer UW-CSS (1989), cited by 1
- K900492: Labeling Change - Viaspan (TM) (Belzer UW) (1990), cited by 1
- K192408: Custodiol HTK Solution (2020), cited by 1
- K020924: Custodiol HTK Solution (2003), cited by 1

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