# K130040: Mepitel AG

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care
- Decided: Feb 12, 2014 after 401 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: 6 generations back to K970566 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984371: Mepitel Non Adherent Silicone Dressing, Molnlycke Health Care, Inc. (1999) Summary page 2.
- K100430: Urgotul AG, Antimicrobial Wound Dressing with Silver, Laboratoires Urgo (2010) Summary page 2.

## Indications for use
MelpiteP Ag is intended for the management of a wide range of exuding wounds such as skin tears, skin abrasions, sutured/surgical wounds, partial thickness burns, partial and ful thickness grafts, lacerations, diabetic ulcers, venous ulcers, end arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.

Source page: https://510kreport.com/device/K130040
Methodology: https://510kreport.com/methodology