# K863390: Hydrocolloid Dressings - Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Sep 30, 1986 after 27 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983249: Sureskin Plus Standard, Sureskin Plus Border, Sureskin Plus Thin (1998), 4 descendants of its own
- K992363: Sureskin II Standard, Sureskin II Border, Sureskin II Thin (1999), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K863390
Methodology: https://510kreport.com/methodology