# K254191: IWD-Gel™

- Pathway: 510(k) (Traditional)
- Applicant: InnovaCorium, Inc.
- Decided: Apr 7, 2026 after 105 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: 8 generations back to K914579 (1992). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173911: Medline Burn and Wound Dressing, Medline Industries, Inc. (2018) Summary page 5.
- K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027, Amerx Health Care Corp. (2009) Summary page 5.

## Indications for use
Rx Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, providing a moist environment, and is indicated for light to moderately exudating wounds such as: • 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 superficial partial thickness burns • donor sites, traumatic and surgical wounds OTC Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, and for the management of minor cuts, abrasions, minor lacerations, and minor burns.

Source page: https://510kreport.com/device/K254191
Methodology: https://510kreport.com/methodology