# NRP: Sirolimus Test System

- Device class: 2; regulation: 21 CFR 862.3840; FDA's rule: 510(k) required
- FDA decisions: 5
- 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)
- 2004: 1
- 2005: 1
- 2007: 1
- 2008: 1
- 2009: 1

## Most-cited predicates
- K042411: Abbott Imx Sirolimus Microparticle Enzyme Immunoassay (2005), cited by 3
- DEN040008: Cedia Sirolimus Assay (2004), cited by 2

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