# K100029: Mepilex Border AG Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care
- Decided: Sep 15, 2010 after 252 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.
9 later devices descend from it; 5 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)
- K061554: Mepilex AG Absorbent Silicone-Coated Dressing, Molnlycke Health Care (2007) Summary page 2.

## Most influential descendants
- K160022: LUOFUCON Silicone Ag foam dressing (2016), 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
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K123756: Covagen (2013), 1 descendant of its own

## Indications for use
Mepilex Border 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. Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.

Source page: https://510kreport.com/device/K100029
Methodology: https://510kreport.com/methodology