# K090453: Silver Alginate 11 Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Advanced Medical Solutions Limited
- Decided: Feb 26, 2009 after 3 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- 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.

## Recalls of this device
- May 25, 2022 · Class III · Z-1806-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi
- May 25, 2022 · Class III · Z-1805-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi
- Jan 15, 2015 · Class II · Z-2719-2016: On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

## Indications for use
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as: Post-operative wounds Trauma wounds (dermal lesions, trauma injuries or incisions) Leg ulcers Pressure ulcers Diabetic ulcers Graft and donor sites Post-operative surgical wounds 1St and 2 nd degree bums Partial and full thickness wounds Silver Alginate II Dressing is indicated for external use only

Source page: https://510kreport.com/device/K090453
Methodology: https://510kreport.com/methodology