# K053590: Silverlon  CA (Calcium Alginate)

- Pathway: 510(k) (Traditional)
- Applicant: Argentum Medical, LLC
- Decided: Oct 6, 2006 after 287 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: 4 generations back to K914575 (1991). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011618: Calgitrol AG Silver Alginate Wound Dressing, Adri (2002)
- K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing, The Westaim Corp. (2001) Summary page 1.
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 1.
- (no number) prior Silverlon products distributed by Argentum Medical, LLC: named in the summary without a submission number

## Most influential descendants
- K192478: LT Antibacterial Alginate with Silver Dressing (2020), 0 descendants of its own

## Indications for use
SilverlonTM CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. SilverlonTM CA Advanced Antimicrobial Dressing is indicated for external use only.

Source page: https://510kreport.com/device/K053590
Methodology: https://510kreport.com/methodology