# K254019: Wound Geni NPWT System

- Pathway: 510(k) (Traditional)
- Applicant: Bechtel Medical, Inc.
- Decided: May 4, 2026 after 140 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172145: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad, Medela AG (2018) Summary page 5.

## Indications for use
The Wound Geni™ NPWT System is indicated for patients who would benefit from a suction device (NPWT). It creates an environment that allows wound management 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. When used on closed surgical incisions, the Wound Geni™ NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy. The Wound Geni™ NPWT System can only be used with Pensar WoundPro Foam Dressing Kits (K150960). The Wound Geni™ NPWT System is appropriate for use for the following indications: • Acute or subacute wounds • Chronic wounds • Dehisced wounds • Pressure ulcers • Diabetic, Neuropathic ulcers • Venous insufficiency ulcers • Traumatic wounds • Partial-thickness burns • Flaps and grafts • Closed surgical incisions

Source page: https://510kreport.com/device/K254019
Methodology: https://510kreport.com/methodology