# K161034: Microcyn Plus Wound Care Solution

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Aug 19, 2016 after 128 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: 11 generations back to K914579 (1992). 60 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141012: Hydrocleanse Wound Care Solution, Oculus Innovative Sciences (2014) Summary page 4.
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ), Puricore, Inc. (2014) Summary page 4.

## Most influential descendants
- K213514: Spectricept Skin and Wound Cleanser (2023), 1 descendant of its own
- K243875: Spectricept Skin and Wound Cleanser (2025), 0 descendants of its own
- K172851: Microcyn Plus Antimicrobial Wound Care Solution (2017), 0 descendants of its own

## Indications for use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms 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 bums, 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: Microcyn Plus is intended for use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Source page: https://510kreport.com/device/K161034
Methodology: https://510kreport.com/methodology