# K240510: Microdacyn Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Pharmaceuticals, Inc.
- Decided: Nov 8, 2024 after 260 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: 5 generations back to K830708 (1983). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093585: Microcyn Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc. (2010) Summary page 5.

## Indications for use
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.

Source page: https://510kreport.com/device/K240510
Methodology: https://510kreport.com/methodology