# K100948: Hypo Clenz Wound Wash Model 100 PPM

- Pathway: 510(k) (Traditional)
- Applicant: Nevoa Life Sciences, LLC
- Decided: Feb 2, 2011 after 302 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical cleansing (irrigation) and removal of dirt, debris and foreign material from minor cuts, minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact skin. Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended to be used by health care professionals in the management, via mechanical irrigation debridement to remove foreign materials including microorganisms; of wounds such as Stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first & second degree burns, grafted and donor sites.

Source page: https://510kreport.com/device/K100948
Methodology: https://510kreport.com/methodology