# K172554: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: May 1, 2018 after 250 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: 5 generations back to K914579 (1992). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120181: Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM, Lufucon Silver Dressing 200X100MM, Huizhou Foryou Medical Devices Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K202982: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (2021), 1 descendant of its own
- K220673: Sterile Silver Alginate Wound Dressing (2023), 0 descendants of its own
- K201016: LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) (2021), 0 descendants of its own

## Indications for use
Luofucon Extra Silver 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. Luofucon Antibacterial Alginate Wound Dressing is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Source page: https://510kreport.com/device/K172554
Methodology: https://510kreport.com/methodology