# MAC: Decontamination Kit

- Device class: 1; regulation: 21 CFR 878.4014
- FDA decisions: 2
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1989: 1
- 2003: 1

## Most-cited predicates
- K894455: Decontaminating Kit, Skin: M291 (1989), cited by 1

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