# MEC: Disinfector, Medical Devices

- Device class: 2; regulation: 21 CFR 880.6992; FDA's rule: 510(k) exempt
- FDA decisions: 2
- Recalls: 10 (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: 1
- 2008: 1

## Most-cited predicates
- K911120: Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21 (1994), cited by 1

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