# K983184: Mepilex

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Oct 28, 1998 after 47 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Cutinova® Foam Dressing: named in the summary without a submission number

## Most influential descendants
- K121361: Curaline Polyurethane Foam Awc Dressing (2012), 0 descendants of its own

## Indications for use
Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

Source page: https://510kreport.com/device/K983184
Methodology: https://510kreport.com/methodology