# K063835: Allevyn AG Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 3, 2007 after 220 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 K000051 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050030: Acticoat Moisture Control Dressing, Smith & Nephew, Inc. (2005) Summary page 2.
- K963096: Allevyn Hydro Poly Dressing ND All Trac Dressing, Smith & Nephew United, Inc. (1996) Summary page 2.

## Most influential descendants
- K110062: Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG (2011), 1 descendant of its own
- K141619: Luofucon Silver Foam Dressing (2015), 0 descendants of its own
- K091013: Silver PU Antibacterial Foam Dressing - Non Adherent and Island (2009), 0 descendants of its own

## Indications for use
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, It and 2nd degree bums, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.

Source page: https://510kreport.com/device/K063835
Methodology: https://510kreport.com/methodology