# SEJ: Wound Dressings Containing Topical Analgesics

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (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)
- 1992: 2
- 2000: 1
- 2002: 1
- 2006: 1
- 2009: 1

## Most-cited predicates
- K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027 (2009), cited by 4
- K053476: Allwound (2006), cited by 1
- K020540: Regenecare Wound Gel (2002), cited by 1
- K912565: Micro-Coll Collagen Wound Spray (1992), cited by 1

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