| K-number | K254019 |
| Device name | Wound Geni NPWT System |
| Applicant | Bechtel Medical, Inc. |
| Product code | OMP |
| Device class | Class II |
| Decision date | May 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4780 |
The Wound Geni™ NPWT System is a negative pressure wound therapy device consisting of an AC/battery-powered control unit with an electric motor-driven vacuum pump, rechargeable lithium-ion battery, and collection canisters. It delivers negative pressure between -75 and -150 mmHg to promote wound healing by reducing edema, promoting granulation tissue formation, and removing exudate and infectious material from acute, chronic, and surgical wounds.
The proposed device operates at -75 to -150 mmHg pressure range compared to the predicate's -60 to -200 mmHg range. Both devices offer continuous/intermittent operating modes, AC/DC power supply with rechargeable battery, and similar portable design. The Wound Geni™ includes 300 and 500 ml canisters versus the predicate's 300 and 800 ml canisters. Both incorporate user-friendly displays, acoustic and optical alarms, and leak detection gauges.
Testing included IEC 60601-1:2005 + A1:2012 for medical electrical equipment safety, IEC 60601-1-2:2014 for electromagnetic compatibility, IEC 62304 for software development and validation, and FDA human factors guidance. Bench performance testing verified pressure accuracy, stability, wound fluid removal, leakage, and alarm functionality.
The Wound Geni™ NPWT System is substantially equivalent to the Invia Liberty predicate device because both are Class II powered suction pumps with the same regulatory classification (21 CFR 878.4780), identical indications for use and contraindications, comparable operating principles delivering negative pressure wound therapy, and substantially similar design and performance characteristics including continuous/intermittent modes and rechargeable battery operation.
View the full FDA submission: accessdata.fda.gov