# K060901: Vashe Wound Cleansing System

- Pathway: 510(k) (Traditional)
- Applicant: Sterilox Technologies, Inc.
- Decided: Jun 29, 2006 after 87 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.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
Vashe TM Wound Cleanser is intended for cleansing, irrigating, moistening, debriding acute and chronic demreal lesions, such as Stage I-IV pressure and 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. The Vashe TM Wound Cleanser is intended for use by qualified health care personnel trained in its use.

Source page: https://510kreport.com/device/K060901
Methodology: https://510kreport.com/methodology