# K141573: Silverlon Island Wound Dressing

- Pathway: 510(k) (Special)
- Applicant: Argentum Medical
- Decided: Aug 28, 2014 after 77 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 K914579 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122817: Silverlon Island Wound Dressing, Argentum Medical, LLC (2014) Summary page 5.

## Indications for use
Silverlon® Island Wound Dressing is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: Under the supervision of a healthcare professional Silverlon® Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral 1V sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-1V pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlon® Island Wound Dressing is indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process. Silverlon® Island Wound Dressing may be used for the management of painful wounds, Silverlon® Island Wound Dressing’s non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Source page: https://510kreport.com/device/K141573
Methodology: https://510kreport.com/methodology