# K050032: Euromed Sureskin Iii with Silver Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Euromed, Inc.
- Decided: May 17, 2006 after 495 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 3 generations back to K853844 (1985). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM), Coloplast Corp. (2002) Summary page 1.
- K024054: Xylos Xcell Antimicrobial Dressing, Xylos Corporation (2003) Summary page 1.
- K992363: Sureskin II Standard, Sureskin II Border, Sureskin II Thin, Euromed, Inc. (1999) Summary page 1.

## Most influential descendants
- K081274: Sureskin Silver Bandages (2008), 1 descendant of its own
- K151186: Stay Fresh Hydrocolloid dressing (2015), 0 descendants of its own

## Indications for use
The SureSkin In with Silver Wound Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. The SureSkin II with Silver BORDER wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkinTM III with Silver THIN wound dressings are indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions. The SureSkinTM III with Silver wound dressings are also indicated for use on second degree bums and donor sites.

Source page: https://510kreport.com/device/K050032
Methodology: https://510kreport.com/methodology