# K231088: Copper Foam Dressing (Prescription and OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Co., Ltd.
- Decided: Jan 11, 2024 after 269 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: 7 generations back to K914579 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180643: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs), Medcu Technologies, Ltd. (2018) Summary page 4.

## Indications for use
Prescription use indications (Rx-only): • Partial and full thickness wounds, • Pressure ulcers (stage I-IV), • Diabetic ulcers, • Venous stasis ulcers, • Arterial ulcers, • 1st and partial thickness burns, • Surgical wounds, • Vascular access or peripheral IV sites, • Orthopedic external pin sites, and • Acute wounds such as lacerations, abrasions, and skin tears. Over-The-Counter (OTC) use indications: Local management of superficial wounds, minor burns, abrasions and lacerations (tears).

Source page: https://510kreport.com/device/K231088
Methodology: https://510kreport.com/methodology