# K131542: Neutrophase (R) Skin and Wound Cleanser Otc

- Pathway: 510(k) (Traditional)
- Applicant: Novabay Pharmaceuticals, Inc.
- Decided: Jul 24, 2013 after 56 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: 9 generations back to K914579 (1992). 39 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113820: Neutrophase Antimicrobial Wound Cleanser, Novabay Pharmaceuticals (2012) Summary page 1.
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser, Oculus Innovative Sciences, Inc. (2009) Summary page 1.

## Most influential descendants
- K141660: Nawalution Skin and Wound Cleanser (2014), 2 descendants of its own
- K252759: revyve® Antimicrobial Skin and Wound Cleanser (2026), 0 descendants of its own
- K231564: Skin and Wound Cleanser (2023), 0 descendants of its own

## Indications for use
NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Source page: https://510kreport.com/device/K131542
Methodology: https://510kreport.com/methodology