# K102943: Coreleader Algi-Fiber Wound Dressing Model Adw 05050

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Apr 12, 2011 after 190 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: 2 generations back to K953497 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910059: Kaltostat Wound Dressing, Calgon Vestal Div. (1991) Summary page 1.
- K983519: Comfeel Seasorb Dressing, Coloplast Corp. (1998) Summary page 1.

## Indications for use
The following indications for use of the product should be managed under the supervision of a health care professional: Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds. The following conditions are considered appropriate for OTC use by the lay person: Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.

Source page: https://510kreport.com/device/K102943
Methodology: https://510kreport.com/methodology