# K140954: Luofucon Silver PU Antibacterial Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Mar 23, 2015 after 343 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). 21 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM, Coloplast A/S (2010) Summary page 5.

## Most influential descendants
- K160022: LUOFUCON Silicone Ag foam dressing (2016), 3 descendants of its own
- 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
- K223359: LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing (2023), 0 descendants of its own

## Indications for use
LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, post-operative wounds and skin abrasions.

Source page: https://510kreport.com/device/K140954
Methodology: https://510kreport.com/methodology