# K123072: Vashe Wound Therapy Solution

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Feb 14, 2013 after 136 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: 8 generations back to K914579 (1992). 35 ancestors in all.
25 later devices descend from it; 6 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100918: Vashe Wound Therapy System Model: 9000-0014, Puricore, Inc. (2010) Summary page 1.

## Most influential descendants
- K133542: Puracyn Plus Skin and Wound (2014), 14 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K181428: Clyra Wound Irrigation Solution (2019), 5 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own
- K142592: CleanSmart Wound Cleanser (2015), 4 descendants of its own

## Indications for use
Vashe* Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding 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 and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. Vasheo Wound Therapy Solution is intended for use by a qualified healthcare personnel trained in its use.

Source page: https://510kreport.com/device/K123072
Methodology: https://510kreport.com/methodology