# KPK: Marker, Ostia, Aorto-Saphenous Vein

- Device class: 2; regulation: 21 CFR 878.4650; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1977: 1
- 1980: 1
- 1986: 1
- 1987: 1
- 1989: 1
- 1998: 1

## Most-cited predicates
- K895369: Voss Graft Marker (1989), cited by 1
- K971966: Coronary Vein Graft Tag Marker (1998), cited by 1
- K864101: Cook (R) Vein Graft Ring Markers (1986), cited by 1

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