# K093320: Dryodine Cadexomer-Iodine Gel

- Pathway: 510(k) (Traditional)
- Applicant: Collegium Pharmaceutical Incorporated
- Decided: Jun 18, 2010 after 238 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: 2 generations back to K940414 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K051542: Triosyn T40 Antimicrobial Wound Dressing, Triosyn Corp. (2006). Our reading of the summary gave K051452, FDA’s number for Sentinel Clin Chem Cal (Sentinel Ch. Srl). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Triosyn T40 Antimicrobial Dressing”.

## Indications for use
DryodineTM Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. DryodineTm Antibacterial Gel assists to keep lesions soft and pliable.

Source page: https://510kreport.com/device/K093320
Methodology: https://510kreport.com/methodology