# K071056: Neutrophase Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Novabay Pharmaceuticals
- Decided: Sep 28, 2007 after 165 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). 6 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060113: Dermacyn Wound Care, Oculus Innovative Sciences, Inc. (2006) Summary page 1.
- K042729: Dermacyn Wound Irrigation, Oculus Innovative Sciences, Inc. (2005)

## Most influential descendants
- K081009: Neutrophase (2008), 16 descendants of its own
- K113820: Neutrophase Antimicrobial Wound Cleanser (2012), 15 descendants of its own
- K131848: Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ) (2014), 8 descendants of its own
- K141012: Hydrocleanse Wound Care Solution (2014), 4 descendants of its own
- K161034: Microcyn Plus Wound Care Solution (2016), 3 descendants of its own

## Indications for use
The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree bums, abrasions and minor irritations of the skin.

Source page: https://510kreport.com/device/K071056
Methodology: https://510kreport.com/methodology