# K192478: LT Antibacterial Alginate with Silver Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Longterm Medical Technology Co., Ltd.
- Decided: Jun 17, 2020 after 281 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 K914604 (1992). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172570: ALGS6 Ag Alginate Wound Dressing, Foshan United Medical Technologies, Ltd. (2018) Summary page 4.
- K053590: Silverlon  CA (Calcium Alginate), Argentum Medical, LLC (2006) Summary page 4.

## Indications for use
LT Antibacterial Alginate with Silver Dressing is used for management acute and chronic wounds, partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, pressure ulcers, donor and graft sites, surgical wounds, traumatic wounds, first and second-degree burns. LT Antibacterial Alginate with Silver Dressing is intended for external use only.

Source page: https://510kreport.com/device/K192478
Methodology: https://510kreport.com/methodology