# K093697: Vashe Wound Therapy Solution

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Apr 13, 2010 after 134 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). 35 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 56 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.
- K041161: Microcyn Wound Care Dressing, Oculus Innovative Sciences, Inc. (2005) Summary page 1.

## Most influential descendants
- K133542: Puracyn Plus Skin and Wound (2014), 14 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
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own

## Indications for use
Vashe® Wound Therapy System is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.

Source page: https://510kreport.com/device/K093697
Methodology: https://510kreport.com/methodology