# K122634: Iodofoam Iodophor Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Progressive Wound Care Technologies, LLC
- Decided: Mar 12, 2013 after 195 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 K905069 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905069: Iodosorb Gel, Perstorp AB C/O Robert Joel Slomoff (1991) Summary page 1.
- K940414: Iodoflex Paste, Oclassen Pharmaceuticals, Inc. (1994) Summary page 1.

## Indications for use
The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.

Source page: https://510kreport.com/device/K122634
Methodology: https://510kreport.com/methodology