# K093349: Medline Curad Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 7, 2010 after 72 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
The intended use is as a wound dressing layer for skin graft recipient sites, newly sutured wounds, abrasions, lacerations and minor or partial thickness burns. These dressings may also be used as an initial layer for wounds with light exudates where deodorization is desired. These dressings are intended for use as a primary layer for donor sites, skin graft recipient sites and minor burns. These dressings may also be used as an initial layer for surgical incision sites and as a seal around tubes and drains exiting the body. These dressings are intended for use as a primary dressing in the management of light to medium draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the care of a health care professional for heavy draining wounds such as surgical incisions, skin grafts and dermal ulcers.

Source page: https://510kreport.com/device/K093349
Methodology: https://510kreport.com/methodology