# K133775: Exsalt SD7 Wound Dressing with Adhesive Backing

- Pathway: 510(k) (Special)
- Applicant: Exciton Technologies, Inc.
- Decided: Mar 26, 2014 after 104 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: 3 generations back to K001519 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103067: Exsalt SD7 Wound Dressing, Exciton Technologies, Inc. (2011) Summary page 2.

## Indications for use
The exsalt SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.

Source page: https://510kreport.com/device/K133775
Methodology: https://510kreport.com/methodology