# SEL: Securement Wound Dressing For Reduction Of Infection

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2001: 1
- 2017: 2

## Most-cited predicates
- K003229: Biopatch Antimicrobial Dressing (2001), cited by 8
- K153410: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (2017), cited by 1

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