# K141012: Hydrocleanse Wound Care Solution

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Aug 8, 2014 after 109 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: 10 generations back to K914579 (1992). 59 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation, Primary Care Solutions, Inc. (2008) Summary page 4.
- K093697: Vashe Wound Therapy Solution, Puricore, Inc. (2010) Summary page 4.
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) 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
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- 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
OTC INDICATIONS: Hydrocleanse™ Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. Rx INDICATIONS: Under the supervision of a healthcare professional, Hydrocleanse™ Solution 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.

Source page: https://510kreport.com/device/K141012
Methodology: https://510kreport.com/methodology