# MKY: System, Skin Closure

- Device class: 1; regulation: 21 CFR 878.4320; FDA's rule: 510(k) exempt
- 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)
- 1994: 2
- 1997: 2
- 1998: 1
- 2001: 1

## Most-cited predicates

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