# K160022: LUOFUCON Silicone Ag foam dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Aug 17, 2016 after 225 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). 24 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100029: Mepilex Border AG Dressing, Molnlycke Health Care (2010) Summary page 5.
- K140954: Luofucon Silver PU Antibacterial Foam Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K170077: LUOFUCON Silicone Ag Foam Dressing with Border (2017), 2 descendants of its own
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (2024), 1 descendant of its own
- K242856: LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (2024), 0 descendants of its own

## Indications for use
LUOFUCON® Silicone Ag foam dressing is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

Source page: https://510kreport.com/device/K160022
Methodology: https://510kreport.com/methodology