# K080503: Silver Alginate IV Antimicrobial Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions Limited
- Decided: Nov 12, 2008 after 261 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K013814: Absorbent Antimicrobial Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (2002) Summary page 2.

## Indications for use
Silver Alginate IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as: · Post-operative wounds · Trauma wounds (denral lesions, trauma injuries or incisions) * Leg Ulcers * Pressures Ulcers • Diabetic Ulcers * Graft and donor sites * Post-operative surgical wounds • 1st and 2 nd degree bums * Partial and Full Thickness wounds Silver Alginate IV Antimicrobial Wound Dressing is indicated for external use only

Source page: https://510kreport.com/device/K080503
Methodology: https://510kreport.com/methodology