# K150256: Silverlon Burn Contact Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Argentum Medical
- Decided: Apr 30, 2015 after 86 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). 18 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023612: Silverlon Contact Wound Dressing, Argentum International, LLC (2003) Summary page 4.
- K073213: Therabond Antimicrobial Barrier Systems, Choice Therapeutics (2008) Summary page 4.
- K122817: Silverlon Island Wound Dressing, Argentum Medical, LLC (2014) Summary page 4.

## Most influential descendants
- K190343: Silverlon Wound Contact, Burn Contact Dressings (2019), 3 descendants of its own
- K221218: Silverlon Wound Contact, Burn Contact Dressings (2022), 1 descendant of its own
- K241225: Silverlon® Wound Contact, Burn Contact Dressing (2024), 0 descendants of its own
- K212521: Field Shield Wound Dressing (2024), 0 descendants of its own

## Indications for use
Silverlon® Wound Contact, Burn Contact Dressings are comprised of a single layer of knitted nylon fiber substrate coated with metallic silver. The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations. Prescription Indications: Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds, surgical wounds (donor and graft sites, incisions), 1st and 2nd degree burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites. Silverlon® dressings are 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® Dressings may help reduce the risk of wound infection and support the body's healing process. Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Burn Contact Dressings is a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Source page: https://510kreport.com/device/K150256
Methodology: https://510kreport.com/methodology