# K081363: Non-Adherent Antimicrobial Alginate Dressing, Silvercel Non-Adherent Antimicrobial Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Limited
- Decided: Sep 24, 2008 after 132 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914575 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024298: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2003) Summary page 1.
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 1.
- K063173: Modification to Silver Alginate II Wound Dressing, Advanced Medical Solutions Limited (2006) Summary page 1.
- K070581: Silver Alginate II Wound Dressing, Advanced Medical Solutions Limited (2007) Summary page 1.

## Indications for use
Non-Adherent Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds. Non-Adherent Antimicrobial Wound Dressing is indicated for external use only.

Source page: https://510kreport.com/device/K081363
Methodology: https://510kreport.com/methodology