# K151186: Stay Fresh Hydrocolloid dressing

- Pathway: 510(k) (Traditional)
- Applicant: Sarasota Medical Products, Inc.
- Decided: Nov 27, 2015 after 207 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: 5 generations back to K853844 (1985). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050032: Euromed Sureskin Iii with Silver Wound Dressings, Euromed, Inc. (2006) Summary page 4.
- K081274: Sureskin Silver Bandages, Euromed, Inc. (2008) Summary page 4.

## Indications for use
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations. OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.

Source page: https://510kreport.com/device/K151186
Methodology: https://510kreport.com/methodology