# K010951: Island Wound Dressing with Microban

- Pathway: 510(k) (Traditional)
- Applicant: Island Dressing, LLC
- Decided: Jun 11, 2001 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Island Wound DressingTM with Microban® is indicated for local management of superficial wounds. Wounds such as vascular access or peripheral IV sites, orthopedic extemnal 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, disbetic ulcers). The dressing should be changed as frequently as needed for proper management of the wound.

Source page: https://510kreport.com/device/K010951
Methodology: https://510kreport.com/methodology