# K201016: LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Jan 28, 2021 after 286 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). 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)
- K082296: Copa Amd, Covidien Lp, Formerly Registered AS Tyco Healthcar (2009) Summary page 4.
- K172554: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2018) Summary page 5.

## Indications for use
Prescription: LUOFUCON® PHMB Alginate Dressing 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: LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor bums.

Source page: https://510kreport.com/device/K201016
Methodology: https://510kreport.com/methodology