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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 / March 2026 / K253429

510(k) cleared

Genadyne ASTRA NPWT

Genadyne Biotechnologies, Inc. · Mar 12, 2026 · K253429

FDA cleared the Genadyne ASTRA NPWT from Genadyne Biotechnologies, Inc. on Mar 12, 2026 under K253429, 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 Oct 1, 2025. The decision came 162 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 Genadyne Biotechnologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253429?

K253429 is the FDA 510(k) for Genadyne ASTRA NPWT, submitted by Genadyne Biotechnologies, Inc.. FDA's decision date was Mar 12, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the Genadyne ASTRA NPWT?

Genadyne Biotechnologies, Inc., based in Hicksville, NY, is the applicant of record for K253429.

How long did the K253429 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Mar 12, 2026, 162 days later.

← All decisions in March 2026