# MKW: Cyclosporine

- Device class: 2; regulation: 21 CFR 862.1235; FDA's rule: 510(k) required
- FDA decisions: 10
- 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)
- 1996: 1
- 2000: 1
- 2002: 4
- 2004: 1
- 2005: 1
- 2006: 2
- 2008: 3

## Most-cited predicates
- K023065: Cyclosporine (Csa) Flex Reagent Cartridge (2002), cited by 1
- K052017: Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108 (2005), cited by 1
- P920031: Emit 2000 Cyclosporine Specific Assay (1996), cited by 1

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