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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 / K240934

510(k) cleared

Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

Spectrum Medical S.R.L. · Mar 12, 2026 · K240934

FDA cleared the Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); from Spectrum Medical S.R.L. on Mar 12, 2026 under K240934, a traditional 510(k). The device falls under product code DTZ, Oxygenator, Cardiopulmonary Bypass, regulated at 21 CFR 870.4350 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 5, 2024. The decision came 706 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spectrum Medical S.R.L. has one other decision in the tracker over the last 12 months: K252541 (Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W).

Questions & Answers

What did FDA clear under K240934?

K240934 is the FDA 510(k) for Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);, submitted by Spectrum Medical S.R.L.. FDA's decision date was Mar 12, 2026, under product code DTZ (Oxygenator, Cardiopulmonary Bypass).

Who makes the Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);?

Spectrum Medical S.R.L., based in Mirandola, is the applicant of record for K240934.

How long did the K240934 review take?

FDA received the submission on Apr 5, 2024 and issued its decision on Mar 12, 2026, 706 days later.

← All decisions in March 2026

Sources