# K081009: Neutrophase

- Pathway: 510(k) (Traditional)
- Applicant: Novabay Pharmaceuticals
- Decided: May 20, 2008 after 42 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945802 (1995). 7 ancestors in all.
16 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)
- K071056: Neutrophase Wound Cleanser, Novabay Pharmaceuticals (2007) Summary page 1.

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

## Indications for use
The device is intended for moistening absorbent wound dressings and cleaning minor cuts, minor bums, 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 bums, abrasions and minor irritations of the skin.

Source page: https://510kreport.com/device/K081009
Methodology: https://510kreport.com/methodology