# NEC: Bandage, Liquid, Skin Protectant

- Device class: 1; regulation: 21 CFR 880.5090; FDA's rule: 510(k) exempt
- FDA decisions: 3
- Recalls: 2 (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)
- 1986: 2
- 1997: 1

## Most-cited predicates
- K861557: Aplicare Skin Protectant Prep Pad (1986), cited by 1

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