# K152741: Mepiseal Soft Silicone Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Jan 22, 2016 after 121 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945062 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141847: Avance Foam Dressing Kits, Molnlycke Health Care Us, LLC (2015) Summary page 4.

## Indications for use
Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy. When used under Negative Pressure Wound Therapy (NPWT) dressings to aid in seal formation, Mepiseal is compatible with Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film.

Source page: https://510kreport.com/device/K152741
Methodology: https://510kreport.com/methodology