# K984208: Silverlon Island Dressing, Silverlon Island Pad

- Pathway: 510(k) (Traditional)
- Applicant: Argentum International, LLC
- Decided: Feb 22, 1999 after 90 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: 3 generations back to K914579 (1992). 6 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910657: Qualtex Island Dressing, Deroyal Industries, Inc. (1991) Summary page 2.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 2.

## Most influential descendants
- K122817: Silverlon Island Wound Dressing (2014), 13 descendants of its own
- 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

## Indications for use
Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings. The Over-The-Counter indications: Local management of superficial wounds, minor burns, abrasions and lacerations. The Prescription Professional indications: Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Source page: https://510kreport.com/device/K984208
Methodology: https://510kreport.com/methodology