# K221218: Silverlon Wound Contact, Burn Contact Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Argentum Medical, Inc.
- Decided: Oct 26, 2022 after 182 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: 7 generations back to K914579 (1992). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190343: Silverlon Wound Contact, Burn Contact Dressings, Argentum Medical, LLC (2019) Summary page 4.
- K063517: Healadex-P, Healagenics, Inc. (2007) Summary page 4.

## Most influential descendants
- K241225: Silverlon® Wound Contact, Burn Contact Dressing (2024), 0 descendants of its own

## Indications for use
Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions, and lacerations. RX Use 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), first and second degree thermal 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@ Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting. Silverlon@ Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury through dry desquamation. Silverlon® Wound Contact, Burn Contact 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® Wound Contact, Burn Contact 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, Wound Burn Dressings are 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/K221218
Methodology: https://510kreport.com/methodology