# K050177: Colactive Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: Apr 27, 2005 after 91 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FIBRACOL PLUS Collagen Wound Dressing with Alginate: named in the summary without a submission number
- (no number) SkinTemp Kollagen Wound Management Material: named in the summary without a submission number

## Most influential descendants
- K123756: Covagen (2013), 1 descendant of its own
- K260652: ColActive Plus (2026), 0 descendants of its own
- K192346: scaffolene CL100 Bioresorbable Collagen Matrix (2020), 0 descendants of its own
- K091338: Collasorb Collagen Wound Dressing (2009), 0 descendants of its own

## Indications for use
ColActive Tm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers Diabetic ulcers Ulcers caused by mixed vascular etiologies Venous ulcers Second degree bums Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention

Source page: https://510kreport.com/device/K050177
Methodology: https://510kreport.com/methodology