# K102946: Coreleader Colla-Pad Model CS 03030

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: May 20, 2011 after 228 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 5 generations back to K881854 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072113: Integra Flowable Wound Matrix, Model FWD301, Integra Lifesciences Corp. (2007) Summary page 1.
- K081635: Integra Meshed Bilayer Wound Matrix, Integra Lifesciences Corp. (2008) Summary page 1.
- K100927: Surgiaid, Maxigen Biotech, Inc. (2011). Cleared while this submission was under review Summary page 1.

## Indications for use
Coreleader Colla-Pad Wound Dressing is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled! undermined wounds, surgical wounds, (donor sites/grafts, post-Mohs surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds.

Source page: https://510kreport.com/device/K102946
Methodology: https://510kreport.com/methodology