# K141660: Nawalution Skin and Wound Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Nawa Heilmittel GmbH
- Decided: Oct 31, 2014 after 133 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: 10 generations back to K914579 (1992). 51 ancestors in all.
2 later devices descend from it; 2 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)
- K113820: Neutrophase Antimicrobial Wound Cleanser, Novabay Pharmaceuticals (2012) Summary page 4.
- K131542: Neutrophase (R) Skin and Wound Cleanser Otc, Novabay Pharmaceuticals, Inc. (2013) Summary page 4.
- K072876: Prontosan Wound Irrigation Solution, B.Braun Medical, Inc. (2008) Summary page 4.
- K110744: Prontosan Wound Irrigation Solution, B.Braun Medical, Inc. (2011) Summary page 4.
- K042084: Bioderm Sciences Wound Healing Spray, Bioderm Sciences, Inc. (2005) Summary page 4.

## Most influential descendants
- 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
NAWAlution for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. NAWAlution for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

Source page: https://510kreport.com/device/K141660
Methodology: https://510kreport.com/methodology