# K111578: Coreleader Colla-Algi Fiber Model Caw

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Sep 23, 2011 after 108 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 K881854 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925548: Fibracol Collagen-Alginate Dressing, Johnson & Johnson Medical, Inc. (1993) Summary page 1.
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K921009: Kaltostat Fortex Wound Dressing, Calgon Vestal Div. (1992) Summary page 1.
- K910059: Kaltostat Wound Dressing, Calgon Vestal Div. (1991) Summary page 1.

## Indications for use
Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including: Full-thickness and partial-thickness wounds Pressure ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Second-degree burns Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical incisions

Source page: https://510kreport.com/device/K111578
Methodology: https://510kreport.com/methodology