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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 / July 2026 / K261335

510(k) cleared

VitalFlow Set with Balance Biosurface

Medtronic, Inc. · Jul 31, 2026 · K261335

FDA cleared the VitalFlow Set with Balance Biosurface from Medtronic, Inc. on Jul 31, 2026 under K261335, a traditional 510(k). The device falls under product code QJZ, Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure, regulated at 21 CFR 870.4100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 23, 2026. The decision came 99 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: K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture), K260195 (Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae), K253203 (Retrograde Coronary Sinus Perfusion Cannulae).

Questions & Answers

What did FDA clear under K261335?

K261335 is the FDA 510(k) for VitalFlow Set with Balance Biosurface, submitted by Medtronic, Inc.. FDA's decision date was Jul 31, 2026, under product code QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure).

Who makes the VitalFlow Set with Balance Biosurface?

Medtronic, Inc., based in Minneapolis, MN, is the applicant of record for K261335.

How long did the K261335 review take?

FDA received the submission on Apr 23, 2026 and issued its decision on Jul 31, 2026, 99 days later.

← All decisions in July 2026