# K150208: Dakin's Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Century Pharmaceuticals, Inc.
- Decided: Jul 21, 2016 after 538 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 K113312 (2012). 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)
- K113312: HY-Chlo (TM)Wound Scrub, Patrin Pharma (2012) Summary page 5.

## Indications for use
Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites. Dakin's Skin and Wound Cleanser is intended for cleansing of minor cuts, minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.

Source page: https://510kreport.com/device/K150208
Methodology: https://510kreport.com/methodology