# K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Mar 31, 2014 after 283 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: 9 generations back to K914579 (1992). 54 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113820: Neutrophase Antimicrobial Wound Cleanser, Novabay Pharmaceuticals (2012) Summary page 1.
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) Summary page 1.
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553, Blairex Laboratories, Inc. (2008) Summary page 1.
- K111313: Exsept Skin and Wound Cleanser with Antimicrobial Preservative, Alcavis Hdc, LLC (2011) Summary page 1.

## Most influential descendants
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own
- K243415: Granudacyn® Wound Irrigation Solution (2025), 1 descendant of its own
- K213514: Spectricept Skin and Wound Cleanser (2023), 1 descendant of its own
- K253665: Vashe Plus Antimicrobial Solution (2026), 0 descendants of its own

## Indications for use
Under the supervision of healthcare professionals, Vashe Wound 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 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.

Source page: https://510kreport.com/device/K131848
Methodology: https://510kreport.com/methodology