# K000051: Acticoat Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Westaim Biomedical, Inc.
- Decided: Apr 5, 2000 after 89 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
92 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K002896: Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing (2001), 83 descendants of its own
- 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

## Recalls of this device
- Apr 15, 2003 · Not classified · Z-0016-04: Product may not meet the established stability specification before the end of labeled expiry date.

Source page: https://510kreport.com/device/K000051
Methodology: https://510kreport.com/methodology