# K203369: Avance Solo Negative Pressure Wound Therapy (NPWT) System

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Jul 1, 2021 after 227 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- 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 K945062 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163387: PICO Single Use Negative Pressure Wound Therapy System, Smith & Nephew Medical Limited (2017) Summary page 4.
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit, Kci USA, Inc. (2012) Summary page 4.

## Indications for use
The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material. Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts. Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.

Source page: https://510kreport.com/device/K203369
Methodology: https://510kreport.com/methodology