# K061554: Mepilex AG Absorbent Silicone-Coated Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care
- Decided: Jan 25, 2007 after 234 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
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Contreet Foam Dressings: named in the summary without a submission number
- (no number) 3M Tegaderm Silver Nonwoven Dressing: named in the summary without a submission number
- (no number) Mepilex Absorbent Silicone-Coated Dressing: named in the summary without a submission number

## Most influential descendants
- K100029: Mepilex Border AG Dressing (2010), 9 descendants of its own
- K160022: LUOFUCON Silicone Ag foam dressing (2016), 3 descendants of its own
- K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings (2009), 3 descendants of its own
- K170077: LUOFUCON Silicone Ag Foam Dressing with Border (2017), 2 descendants of its own
- K123892: Mepilex Transfer AG (2013), 2 descendants of its own

## Indications for use
Mepelix 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/K061554
Methodology: https://510kreport.com/methodology