# K990042: Silon Dual-Dress

- Pathway: 510(k) (Traditional)
- Applicant: Bio Med Sciences, Inc.
- Decided: Mar 19, 1999 after 72 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: 1 generation back to K912032 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912032: Silon (TM) Transparent Wound Dressing, Bio Med Sciences, Inc. (1991) Summary page 1.
- K923150: Silon Transparent Wound Dressings, Bio Med Sciences, Inc. (1992) Summary page 1.
- K971337: Epitech Island Dressings, Rynel, Ltd. Inc. (1997) Summary page 1.

## Indications for use
For the management of partial and full thickness wounds including the following: Second Degree Burns Skin Graft Donor Sites Autograft Sites Abrasions Lacerations Stage II - III Chronic Wounds (Venous Stasis, Decubitus & Diabetic) Skin Tears

Source page: https://510kreport.com/device/K990042
Methodology: https://510kreport.com/methodology