# FZZ: Marker, Skin

- Device class: 1; regulation: 21 CFR 878.4660; FDA's rule: 510(k) exempt
- FDA decisions: 23
- Recalls: 1 (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)
- 1982: 1
- 1983: 3
- 1984: 4
- 1985: 1
- 1986: 3
- 1989: 1
- 1990: 1
- 1991: 2
- 1992: 2
- 2004: 1

## Most-cited predicates
- K790084: Surgical Ruler and Pen (1979), cited by 1

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