# K113820: Neutrophase Antimicrobial Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Novabay Pharmaceuticals
- Decided: Aug 8, 2012 after 225 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: 8 generations back to K914579 (1992). 38 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081009: Neutrophase, Novabay Pharmaceuticals (2008) Summary page 1.
- K100918: Vashe Wound Therapy System Model: 9000-0014, Puricore, Inc. (2010) Summary page 1.
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 1.
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel, Anacapa Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K131542: Neutrophase (R) Skin and Wound Cleanser Otc (2013), 3 descendants of its own
- K141660: Nawalution Skin and Wound Cleanser (2014), 2 descendants of its own

## Indications for use
NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including micro-organisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding 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 burns, grafted and donor sites.

Source page: https://510kreport.com/device/K113820
Methodology: https://510kreport.com/methodology