# K161991: Curasite

- Pathway: 510(k) (Traditional)
- Applicant: Izun Pharmaceuticals
- Decided: Mar 3, 2017 after 227 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Under the supervision of a healthcare professional, Curasite is intended for the management of the following: • Diabetic foot ulcers • Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) • Pressure ulcers/sores (partial and full thickness) • 1st and 2nd degree partial thickness burns For Over-the-Counter (OTC) use, Curasite may be used for the management of: • Minor abrasions • Minor lacerations • Minor cuts • Minor scalds and minor burns

Source page: https://510kreport.com/device/K161991
Methodology: https://510kreport.com/methodology