# K992363: Sureskin II Standard, Sureskin II Border, Sureskin II Thin

- Pathway: 510(k) (Special)
- Applicant: Euromed, Inc.
- Decided: Aug 12, 1999 after 28 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: 2 generations back to K853844 (1985). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983249: Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin, Euromed, Inc. (1998) Summary page 1.
- K960393: Sureskin Border, Euromed A/S (1996) Summary page 1.
- K960394: Sureskin Standard, Euromed A/S (1996) Summary page 1.
- K960404: Sureskin Thin, Euromed A/S (1996) Summary page 1.
- K863390: Hydrocolloid Dressings - Sterile, Convatec, A Division of E.R. Squibb & Sons (1986) Summary page 1.

## Most influential descendants
- K050032: Euromed Sureskin Iii with Silver Wound Dressings (2006), 2 descendants of its own
- 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 II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers. The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers; post-operative wounds, superficial wounds and abrasions. The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.

Source page: https://510kreport.com/device/K992363
Methodology: https://510kreport.com/methodology