# NAD: Dressing, Wound, Occlusive

- Device class: 1; regulation: 21 CFR 878.4020; FDA's rule: 510(k) exempt
- FDA decisions: 108
- Recalls: 13 (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)
- 1997: 1
- 1999: 1
- 2000: 1
- 2002: 1
- 2005: 1
- 2006: 1
- 2008: 2
- 2009: 1
- 2011: 1
- 2026: 1

## Most-cited predicates
- K990530: Kerlix MD Antimicrobial Gauze Dressing (2000), cited by 5
- K020781: Wet Chamber (2002), cited by 3
- K881050: Duoderm (R) CGF (1988), cited by 2
- K871166: Allevyn Hydrophilic Polyurethane Dressing (1987), cited by 2
- K890354: Tegapore Wound Contact Material, Product #563X (1989), cited by 2
- K860085: Lyofoam Wound Dressings (1986), cited by 1
- K881731: AD-Heal (TM) Wound Dressing (1988), cited by 1
- K060046: Dermastream (2006), cited by 1
- K891696: Duoderm* Extra Thin Flexible Hydrocolloid Dressing (1989), cited by 1
- K864011: Exu-Dry Burn/Trauma Dressing, Various Sizes (1986), cited by 1

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