# MGP: Dressing, Wound And Burn, Occlusive

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 80
- Recalls: 1 (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: 4
- 1992: 5
- 1993: 5
- 1994: 7
- 1995: 19
- 1996: 9
- 1997: 9
- 1998: 12
- 1999: 7
- 2001: 3

## Most-cited predicates
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres (1997), cited by 8
- K984371: Mepitel Non Adherent Silicone Dressing (1999), cited by 4
- K973657: Arglaes-AB  Antimicrobial Barrier Island Dressing (1997), cited by 3
- K973538: N-Terface (1997), cited by 2
- K982939: BTF Thin Film Wound Dressing (1998), cited by 2
- K973312: Transparent Film Dressing, Intelligent Film Dressing (1997), cited by 2
- K960393: Sureskin Border (1996), cited by 2
- K960404: Sureskin Thin (1996), cited by 2
- K960394: Sureskin Standard (1996), cited by 2
- K912032: Silon (TM) Transparent Wound Dressing (1991), cited by 2

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