# K974354: Mepiform Adherent Silicone Dressing for Scar Care

- Pathway: 510(k) (Traditional)
- Applicant: Sca Molnlycke
- Decided: Mar 5, 1998 after 106 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Smith & Nephew Cica-Care™ Adhesive Gel Sheet: named in the summary without a submission number

## Most influential descendants
- K024057: Curad Scar Therapy (2003), 0 descendants of its own
- K991970: Scarease Sheets & Scarease Gel (1999), 0 descendants of its own

## Indications for use
Mepiform Adherent Silicone Dressing is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on closed wounds which may prevent hypertrophic or keloid scarring.

Source page: https://510kreport.com/device/K974354
Methodology: https://510kreport.com/methodology