# K233614: Genadyne DUO NPWT

- Pathway: 510(k) (Traditional)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Dec 23, 2024 after 406 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: 5 generations back to K945062 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162790: V.A.C.ULTA Negative Pressure Wound Therapy System, Kci USA, Inc. (Kinetic Concepts, Inc.) (2017) Summary page 5.

## Indications for use
The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. • The Genadyne DUO NPWT System, in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. • Instillation therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Source page: https://510kreport.com/device/K233614
Methodology: https://510kreport.com/methodology