# K043296: Colactive AG Collagen with Silver Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Covalontechnologies, Inc.
- Decided: Jun 6, 2005 after 189 days
- Product code: FRO (Dressing, Wound, Drug)
- 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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) Vitaphore Silver Foam Wound Dressing: named in the summary without a submission number
- (no number) Acticoat Silver Coated Dressing: named in the summary without a submission number

## Most influential descendants
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold (2010), 6 descendants of its own
- K052696: Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing (2006), 5 descendants of its own
- K120605: Permacol Surgical Implant (2012), 4 descendants of its own
- K063059: Sorbact Wound Dressing (2007), 4 descendants of its own
- K160181: Colorado Therapeutics Xenograft Implant (2016), 1 descendant of its own

## Indications for use
ColActive Ag T Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness including: * Pressure ulcers * Diabetic ulcers * Ulcers caused by mixed vascular etiologies * Venous ulcers * First and Second degree bums * Donor and graft sites * Abrasions & lacerations * Dehisced surgical wounds * Traumatic wounds healing by secondary intention

Source page: https://510kreport.com/device/K043296
Methodology: https://510kreport.com/methodology