# K202982: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)

- Pathway: 510(k) (Traditional)
- Applicant: Winner Medical Co., Ltd.
- Decided: Oct 19, 2021 after 384 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: 6 generations back to K914579 (1992). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172554: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K220673: Sterile Silver Alginate Wound Dressing (2023), 0 descendants of its own

## Indications for use
Prescription: Silver Alginate Dressing (Prescription use) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. OTC: Antibacterial Alginate Wound Dressing (OTC use) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor bums.

Source page: https://510kreport.com/device/K202982
Methodology: https://510kreport.com/methodology