# K233399: Microdacyn Wound Care Solution

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Pharmaceuticals, Inc.
- Decided: Sep 13, 2024 after 345 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: 13 generations back to K914579 (1992). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172622: Microcyn Antimicrobial Skin and Wound Cleanser, Sonoma Pharmaceuticals (2017) Summary page 5.
- K181074: Simple Science Antimicrobial Facial and Eyelid Cleanser, Simple Science, LLC (2018) Summary page 5.

## Most influential descendants
- K261023: Microdacyn Wound Irrigation Solution (2026), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, Microdacyn Wound Care Solution 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. Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

Source page: https://510kreport.com/device/K233399
Methodology: https://510kreport.com/methodology