# NAC: Dressing, Wound, Hydrophilic

- Device class: 1; regulation: 21 CFR 878.4018; FDA's rule: 510(k) exempt
- FDA decisions: 4
- Recalls: 6 (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)
- 1991: 2
- 1993: 1
- 2008: 1

## Most-cited predicates
- K914575: Sorbsan Topical Wound Dressing (Modified) (1991), cited by 3
- K914779: Alginate Fiber (1991), cited by 2

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