# K071354: Mepilex AG Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Monlycke Health Care
- Decided: Jul 13, 2007 after 59 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 K061554 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing, Molnlycke Health Care (2007) Summary page 1.

## Most influential descendants
- K091013: Silver PU Antibacterial Foam Dressing - Non Adherent and Island (2009), 0 descendants of its own

## Indications for use
Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.

Source page: https://510kreport.com/device/K071354
Methodology: https://510kreport.com/methodology