# K220673: Sterile Silver Alginate Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Bright Moon Biomedical Materials Co., Ltd.
- Decided: Mar 16, 2023 after 374 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202982: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use), Winner Medical Co., Ltd. (2021) Summary page 4.

## Indications for use
Sterile Silver Alginate Wound Dressing (Rx only) 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. Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Source page: https://510kreport.com/device/K220673
Methodology: https://510kreport.com/methodology