# K172622: Microcyn Antimicrobial Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Pharmaceuticals
- Decided: Nov 21, 2017 after 81 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: 7 generations back to K914579 (1992). 28 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 4.
- K171727: Hydrocleanse Antimicrobial Skin and Wound Care Solution, Sonoma Pharmaceuticals (2017) Summary page 4.

## Most influential descendants
- K233399: Microdacyn Wound Care Solution (2024), 1 descendant of its own
- K261023: Microdacyn Wound Irrigation Solution (2026), 0 descendants of its own
- K220286: ELECTROCYN soma (2022), 0 descendants of its own

## Indications for use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Antimicrobial Skin and Wound Cleanser is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds. OTC Indications for Use: Microcyn Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Source page: https://510kreport.com/device/K172622
Methodology: https://510kreport.com/methodology