# K140147: BCT Antimicrobial Dressing & BCT Silver Bandage

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Carbon Technology Co., Ltd.
- Decided: Apr 22, 2014 after 90 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: 4 generations back to K914575 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022483: Actisorb Silver 220 Antimicrobial Binding Dressing, Johnson & Johnson Medical, Ltd. (2003) Summary page 2.

## Indications for use
The BCT Antimicrobial Dressing & BCT Silver Bandage Dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as: * Partial and full thickness wounds; * Pressure ulcers; * Diabetic ulcers; * Surgical wounds; * Acute wounds (1st and 2nd degree burns)

Source page: https://510kreport.com/device/K140147
Methodology: https://510kreport.com/methodology