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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 / December 2025 / K250319

510(k) cleared

MFUSE (MS001)

Machina Medical, Inc. · Dec 15, 2025 · K250319

FDA cleared the MFUSE (MS001) from Machina Medical, Inc. on Dec 15, 2025 under K250319, a traditional 510(k). The device falls under product code QSY, Hemostatic Wound Dressing Without Thrombin Or Other Biologics as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Feb 4, 2025. The decision came 314 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 Machina Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250319?

K250319 is the FDA 510(k) for MFUSE (MS001), submitted by Machina Medical, Inc.. FDA's decision date was Dec 15, 2025, under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics).

Who makes the MFUSE (MS001)?

Machina Medical, Inc., based in Roswell, GA, is the applicant of record for K250319.

How long did the K250319 review take?

FDA received the submission on Feb 4, 2025 and issued its decision on Dec 15, 2025, 314 days later.

← All decisions in December 2025