# K092232: Modification to:Vashe Wound Cleansing System, Model 9000-0014

- Pathway: 510(k) (Special)
- Applicant: Puricore, Inc.
- Decided: Aug 19, 2009 after 27 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: 4 generations back to K945802 (1995). 9 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965120: Allclenz Wound Cleanser, Dpt Laboratories, Ltd. (1997) Summary page 1.
- K022670: Carraklenz and Ultraklenz, Carrington Laboratories, Inc. (2002) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K041161: Microcyn Wound Care Dressing, Oculus Innovative Sciences, Inc. (2005) Summary page 1.
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 1.

## Most influential descendants
- K113693: Nixall TM Wound and Skin Care (2012), 15 descendants of its own
- 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

## Indications for use
Vashe® Wound Cleanser 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 bums, abrasions and minor irritations of the skin in, addition to moistening and lubricating absorbent wound dressings. The Vashe® Wound Cleanser is intended for used by qualified health care personnel trained in its use

Source page: https://510kreport.com/device/K092232
Methodology: https://510kreport.com/methodology