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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 / K254208

510(k) cleared

FLOWRUNNER Aspiration System

Expanse Medical, Inc. · Mar 20, 2026 · K254208

FDA cleared the FLOWRUNNER Aspiration System from Expanse Medical, Inc. on Mar 20, 2026 under K254208, a special 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K254208?

K254208 is the FDA 510(k) for FLOWRUNNER Aspiration System, submitted by Expanse Medical, Inc.. FDA's decision date was Mar 20, 2026, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the FLOWRUNNER Aspiration System?

Expanse Medical, Inc., based in Pleasanton, CA, is the applicant of record for K254208.

How long did the K254208 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 20, 2026, 81 days later.

← All decisions in March 2026