# K213598: LUOFUCON Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Sep 20, 2022 after 309 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: 1 generation back to K060456 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060456: Medline Collagen Wound Dressing, Medline Industries, Inc. (2006) Summary page 4.

## Indications for use
LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, venous ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

Source page: https://510kreport.com/device/K213598
Methodology: https://510kreport.com/methodology