# K191819: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: May 14, 2020 after 314 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: 7 generations back to K914579 (1992). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120828: Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches, Coloplast A/S (2012) Summary page 4.
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM, Coloplast A/S (2010) Summary page 5.

## Most influential descendants
- K221754: Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) (2023), 0 descendants of its own

## Indications for use
The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.

Source page: https://510kreport.com/device/K191819
Methodology: https://510kreport.com/methodology