# K260652: ColActive Plus

- Pathway: 510(k) (Traditional)
- Applicant: Covalon Technologies, Ltd.
- Decided: Sep 9, 2026 after 194 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 K050177 (2005). 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)
- K050177: Colactive Collagen Wound Dressing, Covalontechnologies, Inc. (2005) Summary page 5.

## Indications for use
ColActive Plus is indicated for use in adult patients for the management of full and partial thickness wounds including: • Pressure ulcers, • Diabetic ulcers, • Ulcers caused by mixed vascular etiologies, • Venous ulcers, • Surgical wounds, • Abrasions and lacerations, • Traumatic wounds, and • Partial thickness burns.

Source page: https://510kreport.com/device/K260652
Methodology: https://510kreport.com/methodology