# K261023: Microdacyn Wound Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Pharmaceuticals, Inc.
- Decided: Jun 24, 2026 after 86 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: 14 generations back to K914579 (1992). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233399: Microdacyn Wound Care Solution, Sonoma Pharmaceuticals, Inc. (2024) Summary page 5.
- K243415: Granudacyn® Wound Irrigation Solution, P.G.F. Industry Solutions GmbH (2025) Summary page 5.

## Indications for use
Rx Indications for Use: Under the supervision of healthcare professionals, Microdacyn Wound Irrigation Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/or dirty wounds, acute and chronic dermal lesions, such as Stage I–IV pressure ulcers, stasis ulcers, diabetic ulcers, post‑surgical wounds, first and partial thickness second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings. OTC Indications for Use: Microdacyn Wound Irrigation 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/K261023
Methodology: https://510kreport.com/methodology