# K180643: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

- Pathway: 510(k) (Traditional)
- Applicant: Medcu Technologies, Ltd.
- Decided: Nov 23, 2018 after 256 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). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing, Argentum Medical (2014) Summary page 5.
- K964468: Iamin Wet Dressing (Copper-Saline), Procyte Corp. (1997) Summary page 5.

## Most influential descendants
- K231088: Copper Foam Dressing (Prescription and OTC) (2024), 0 descendants of its own

## Indications for use
The MedCu Antibacterial Wound Dressings with Copper-Oxide are indicated for the management of wounds and to provide a physical bacterial barrier (adhesive contour type only). The dressings are applied topically and are in direct contact with the wound. The dressings are intended to be used for indications as follows: Over-The-Counter (OTC) use indications: Local management of superficial wounds, minor burns, abrasions and lacerations (tears). Prescription use indications (Rx-only): • Partial and full thickness wounds, • Pressure ulcers (stage I-IV), • Diabetic ulcers, • Venous stasis ulcers, • Arterial ulcers, • 1st and 2nd degree burns, • Surgical wounds, • Vascular access or peripheral IV sites, • Orthopedic external pin sites, and • Acute wounds such as lacerations, abrasions, and skin tears.

Source page: https://510kreport.com/device/K180643
Methodology: https://510kreport.com/methodology