# K914604: Mepitel Non-Adherent Silicone Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Clinical Products AB
- Decided: Mar 25, 1992 after 160 days
- Product code: NAB (Gauze / Sponge,Nonresorbable For External Use)
- Device class: 1
- Regulation: 21 CFR 878.4014
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
82 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K984371: Mepitel Non Adherent Silicone Dressing (1999), 81 descendants of its own
- 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

Source page: https://510kreport.com/device/K914604
Methodology: https://510kreport.com/methodology