# K992221: Acticoat Primary Antimicrobial Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Westaim Biomedical, Inc.
- Decided: Jun 7, 2000 after 342 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: 3 generations back to K914579 (1992). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983833: Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive, Westaim Biomedical, Inc. (1998). Our OCR of the scanned summary read K983883, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acticoat® Composite dressing”.
- K973538: N-Terface, Winfield Laboratories, Inc. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K820298: Carcinoembryonic Antigen Control (4 Lev, Ventrex Laboratories, Inc. (1982). Our OCR of the scanned summary read K820298, FDA’s number for Carcinoembryonic Antigen Control (4 Lev (Ventrex Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “N'Terface dressing”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K011941: Excilon Amd Antimicrobial Sponge Model #7088 (2001), 1 descendant of its own
- K070685: Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662 (2007), 0 descendants of its own
- K050086: Brennen Medical Silver Glucan Wound Dressing (2006), 0 descendants of its own

## Indications for use
The Acticoat® silver coated contact layer dressing is an effective barrier to bacterial and fungal penetration.! The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.

Source page: https://510kreport.com/device/K992221
Methodology: https://510kreport.com/methodology