# K060456: Medline Collagen Wound Dressing

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Jun 19, 2006 after 117 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K231152: Collagen Wound Dressing (2023), 1 descendant of its own
- K252001: Collagen Wound Dressing (2025), 0 descendants of its own
- K213598: LUOFUCON Collagen Wound Dressing (2022), 0 descendants of its own

## Recalls of this device
- Feb 10, 2026 · Class II · Z-1650-2026: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as feve

## Indications for use
Medline's Collagen 'Wound Dressing is indicated 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 and full thickness bums * Donor sites and other bleeding surface wounds * Abrasions * Traumatic wounds healing by secondary intention * Dehisced surgical incisions These dressings may be cut to size and may be layered for the management of deep wounds.

Source page: https://510kreport.com/device/K060456
Methodology: https://510kreport.com/methodology