# K210718: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Mar 23, 2022 after 378 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 K914604 (1992). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec, Inc. (2012) Summary page 5.
- K183645: Silver High Performance Dressing, Advanced Medical Solutions, Ltd. (2019) Summary page 5.

## Most influential descendants
- K240485: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (2024), 0 descendants of its own
- K221110: LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing (2024), 0 descendants of its own

## Indications for use
Prescription: LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including: Partial thickness burns (second degree); Diabetic foot ulcers; Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Pressure ulcers (partial and full thickness); Donor sites; Surgical wounds; Traumatic wounds. OTC: LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.

Source page: https://510kreport.com/device/K210718
Methodology: https://510kreport.com/methodology