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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K254019

510(k) cleared

Wound Geni NPWT System

Bechtel Medical, Inc. · May 4, 2026 · K254019

FDA cleared the Wound Geni NPWT System from Bechtel Medical, Inc. on May 4, 2026 under K254019, a traditional 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 15, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bechtel Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254019?

K254019 is the FDA 510(k) for Wound Geni NPWT System, submitted by Bechtel Medical, Inc.. FDA's decision date was May 4, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the Wound Geni NPWT System?

Bechtel Medical, Inc., based in Collegeville, PA, is the applicant of record for K254019.

How long did the K254019 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on May 4, 2026, 140 days later.

← All decisions in May 2026