# FJD: Detector, Leak, Blood

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1999: 1
- 2001: 1
- 2004: 1
- 2013: 1

## Most-cited predicates
- K990206: Serim Blood Leak Test Strip (1999), cited by 2
- K012115: Serim Blood Leak Test Strip-2 (2001), cited by 1

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