# K142775: Neuwater TM (HydrocynTM aqua)

- Pathway: 510(k) (Traditional)
- Applicant: Vigilenz Medical Devices
- Decided: Feb 13, 2015 after 140 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
Prescription Use: Neuwater (Hydrocyn aqua) is intended for 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 burns, abrasions and minor irritation of the skin. Over-the-Counter: Neuwater (Hydrocyn aqua) is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

Source page: https://510kreport.com/device/K142775
Methodology: https://510kreport.com/methodology