# K223526: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical Limited
- Decided: Aug 18, 2023 after 268 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 K061554 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100029: Mepilex Border AG Dressing, Molnlycke Health Care (2010) Summary page 4.

## Indications for use
ALLEVYN Ag+ dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. ALLEVYN Ag+ dressing can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing. ALLEVYN Ag+ dressing should be used under the supervision of a qualified healthcare professional.

Source page: https://510kreport.com/device/K223526
Methodology: https://510kreport.com/methodology