# K190756: Iodoflex

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Medical, Ltd.
- Decided: Dec 20, 2019 after 270 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: 1 generation back to K940414 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940414: Iodoflex Paste, Oclassen Pharmaceuticals, Inc. (1994) Summary page 4.

## Indications for use
IODOFLEX is indicated for use in managing wet ulcers and wounds such as venous stasis ulcers, pressure sores, and infected traumatic and surgical wounds. IODOFLEX assists in wound area protection and in reducing the microbial load in the wound dressing, retards eschar formation and keeps the lesion soft and pliable.

Source page: https://510kreport.com/device/K190756
Methodology: https://510kreport.com/methodology