# K100918: Vashe Wound Therapy System Model: 9000-0014

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Aug 9, 2010 after 129 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: 7 generations back to K914579 (1992). 34 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 1.
- K090725: Oculus Microcyn Wound Gel, Oculus Innovative Sciences, Inc. (2009) Summary page 1.

## Most influential descendants
- K123072: Vashe Wound Therapy Solution (2013), 25 descendants of its own
- K113820: Neutrophase Antimicrobial Wound Cleanser (2012), 15 descendants of its own
- 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

## Indications for use
Vashe®D Wound Therapy System (including 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 wouinds, first and second degree bums, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings. The Vashe® Wound Therapy System is intended for used by qualified health care personnel trained in its use

Source page: https://510kreport.com/device/K100918
Methodology: https://510kreport.com/methodology