# K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: The Westaim Corp.
- Decided: Feb 21, 2001 after 156 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
Longest line of descent: 2 generations back to K914575 (1991). 4 ancestors in all.
83 later devices descend from it; 5 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000051: Acticoat Foam Dressing, Westaim Biomedical, Inc. (2000) Summary page 1.
- K983210: Algisite M, Smith & Nephew, Inc. (1998) Summary page 1.

## Most influential descendants
- K024298: Antimicrobial Alginate Dressing (2003), 53 descendants of its own
- K032986: Clo-Surplusp.a.D. (2004), 25 descendants of its own
- K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) (2004), 17 descendants of its own
- K041316: Antimicrobial Alginate Dressing (2004), 16 descendants of its own
- K022483: Actisorb Silver 220 Antimicrobial Binding Dressing (2003), 12 descendants of its own

## Indications for use
The Acticoat® Caleium Alginate Dressing is an effective barrier to bacterial penetration., The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.

Source page: https://510kreport.com/device/K002896
Methodology: https://510kreport.com/methodology