# K090791: Dakin's Antimicrobial Wound Cleanser, Model 0.0125% to 5%

- Pathway: 510(k) (Traditional)
- Applicant: Century Pharmaceuticals, Inc.
- Decided: Aug 7, 2009 after 136 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: 6 generations back to K914579 (1992). 26 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K111313: Exsept Skin and Wound Cleanser with Antimicrobial Preservative (2011), 9 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K243415: Granudacyn® Wound Irrigation Solution (2025), 1 descendant of its own

## Indications for use
OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree bums, grafted and donor sites. The sodium hypochlorite concentration of 0.0125% weight / volume.

Source page: https://510kreport.com/device/K090791
Methodology: https://510kreport.com/methodology