# K254246: LT Antibacterial Foam with Silver Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Longterm Medical Technology Co., Ltd.
- Decided: Sep 10, 2026 after 255 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- 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.
No later device cites it as a predicate yet.
0 of 22 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.

## Indications for use
LT Antibacterial Foam with Silver Dressing is indicated for management acute and chronic wounds with moderate to heavy exudate, including stage II, III and IV pressure ulcers, leg ulcers and diabetic foot ulcers. The dressing can also be used for partial thickness burns (including first- and superficial second-degree burns), donor sites, post operative wounds and skin abrasions. LT Antibacterial Foam with Silver Dressing is intended for external use only.

Source page: https://510kreport.com/device/K254246
Methodology: https://510kreport.com/methodology