# K983833: Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Westaim Biomedical, Inc.
- Decided: Dec 10, 1998 after 41 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914579 (1992). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955453: Acticoat Silver Coated Dressing, Westaim Technologies, Inc. (1996) Summary page 2.
- (no number) Bioderm’s Composite Wound Dressing: named in the summary without a submission number
- (no number) Conformant 2® Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K992221: Acticoat Primary Antimicrobial Dressing (2000), 3 descendants of its own
- K032463: Curad Silver Bandage (2004), 2 descendants of its own
- K011941: Excilon Amd Antimicrobial Sponge Model #7088 (2001), 1 descendant of its own
- K100580: Exsalt Wound Dressing (2010), 0 descendants of its own
- K082910: CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver Bandages (2009), 0 descendants of its own

## Indications for use
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.

Source page: https://510kreport.com/device/K983833
Methodology: https://510kreport.com/methodology