# K122817: Silverlon Island Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Argentum Medical, LLC
- Decided: May 1, 2014 after 594 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 K914579 (1992). 15 ancestors in all.
13 later devices descend from it; 4 cite 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)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 1.
- K083113: Acticoat Flex 7 Dressing, Smith & Nephew, Inc. (2009) Summary page 2.
- K984208: Silverlon Island Dressing, Silverlon Island Pad, Argentum International, LLC (1999) Summary page 2.

## Most influential descendants
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (2014), 5 descendants of its own
- K150256: Silverlon Burn Contact Dressings (2015), 4 descendants of its own
- 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
- K180570: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) (2019), 1 descendant of its own

## Indications for use
Silverlon®D Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing. The Over-The-Counter Indications: Local management of superficial wounds, minor bums, abrasions and lacerations. 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 IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness denmal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlong 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. SilverlonS Island Wound Dressing may be used for the management of painful wounds' Silverlon®D Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound. 'Clarified/New Indication, not previously included in this format under K984208.

Source page: https://510kreport.com/device/K122817
Methodology: https://510kreport.com/methodology