# K151168: Nexodyn AOS Wound Care Solution

- Pathway: 510(k) (Traditional)
- Applicant: Apr Applied Pharma Research SA
- Decided: Dec 22, 2015 after 235 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). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 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 6.
- K123072: Vashe Wound Therapy Solution, Puricore, Inc. (2013) Summary page 6.

## Indications for use
Nexodyn AOS Wound Care Solution is intended for use under the supervision of healthcare professionals for cleansing, irrigating, moistening and debriding, to remove organic and inorganic debris from partial or full thickness acute and chronic dermal lesions, such as leg ulcers, stasis ulcers, diabetic ulcers, stage I-IV pressure ulcers, post-surgical wounds, grafted and donor sites and 1st and 2nd degree burns, together with cleansing and moistening minor cuts, minor burns, superficial abrasions and minor skin irritations.

Source page: https://510kreport.com/device/K151168
Methodology: https://510kreport.com/methodology