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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 / January 2026 / K251831

510(k) cleared

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc. · Jan 15, 2026 · K251831

FDA cleared the Bio-Medicus Life Support Catheter and Introducer from Medtronic, Inc. on Jan 15, 2026 under K251831, a traditional 510(k). The device falls under product code QHW, Single Lumen Ecmo Cannula, regulated at 21 CFR 870.4100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 13, 2025. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture), K260195 (Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae).

Questions & Answers

What did FDA clear under K251831?

K251831 is the FDA 510(k) for Bio-Medicus Life Support Catheter and Introducer, submitted by Medtronic, Inc.. FDA's decision date was Jan 15, 2026, under product code QHW (Single Lumen Ecmo Cannula).

Who makes the Bio-Medicus Life Support Catheter and Introducer?

Medtronic, Inc., based in Minneapolis, MN, is the applicant of record for K251831.

How long did the K251831 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Jan 15, 2026, 216 days later.

← All decisions in January 2026