# K050030: Acticoat Moisture Control Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 21, 2005 after 104 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: 1 generation back to K000051 (2000). 1 ancestor in all.
9 later devices descend from it; 3 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)
- K000051: Acticoat Foam Dressing, Westaim Biomedical, Inc. (2000) Summary page 2.

## Most influential descendants
- K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings (2009), 3 descendants of its own
- K063835: Allevyn AG Dressing (2007), 3 descendants of its own
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K110062: Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG (2011), 1 descendant of its own
- K242856: LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (2024), 0 descendants of its own

## Indications for use
The Acticoat® Moisture Control Dressing is indication for use in light to moderately exuding partial thickness wounds including decubitus ulcers, 1st and 2 nd degree bums, and donor sites. Acticoat Moisture Control may be used over debrided and partial thickness wounds

Source page: https://510kreport.com/device/K050030
Methodology: https://510kreport.com/methodology