# K984371: Mepitel Non Adherent Silicone Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Mar 3, 1999 after 86 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
Longest line of descent: 1 generation back to K914604 (1992). 1 ancestor in all.
81 later devices descend from it; 4 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914604: Mepitel Non-Adherent Silicone Dressing, Molnlycke Clinical Products AB (1992) Summary page 1.

## Most influential descendants
- K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing (2007), 59 descendants of its own
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing (2008), 54 descendants of its own
- K141847: Avance Foam Dressing Kits (2015), 14 descendants of its own
- K122817: Silverlon Island Wound Dressing (2014), 13 descendants of its own
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber (2012), 13 descendants of its own

## Indications for use
Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Source page: https://510kreport.com/device/K984371
Methodology: https://510kreport.com/methodology