# K955453: Acticoat Silver Coated Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Westaim Technologies, Inc.
- Decided: May 31, 1996 after 184 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: 1 generation back to K914579 (1992). 1 ancestor in all.
161 later devices descend from it; 7 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914579: Silver Foam Wound Dressing, Vitaphore Corp. (1992) Summary page 2.

## Most influential descendants
- K981299: Silverlon Contact Wound Dressing (1998), 149 descendants of its own
- K023612: Silverlon Contact Wound Dressing (2003), 102 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own

## Indications for use
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.

Source page: https://510kreport.com/device/K955453
Methodology: https://510kreport.com/methodology