# K120181: Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM, Lufucon Silver Dressing 200X100MM

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Feb 14, 2013 after 391 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: 4 generations back to K914579 (1992). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041316: Antimicrobial Alginate Dressing, Advanced Medical Solutions, Ltd. (2004) Summary page 1.
- K023612: Silverlon Contact Wound Dressing, Argentum International, LLC (2003) Summary page 1.

## Most influential descendants
- K172554: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing (2018), 3 descendants of its own
- K202982: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) (2021), 1 descendant of its own
- K143335: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) (2015), 1 descendant of its own
- K230190: Polyver Silver Alginate Dressing (Prescription and OTC) (2023), 0 descendants of its own
- K220673: Sterile Silver Alginate Wound Dressing (2023), 0 descendants of its own

## Indications for use
OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and bums. Prescription: Luofucon 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.

Source page: https://510kreport.com/device/K120181
Methodology: https://510kreport.com/methodology