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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 / K252541

510(k) cleared

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Spectrum Medical S.R.L. · Mar 12, 2026 · K252541

FDA cleared the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W from Spectrum Medical S.R.L. on Mar 12, 2026 under K252541, a traditional 510(k). The device falls under product code DTR, Heat-Exchanger, Cardiopulmonary Bypass, regulated at 21 CFR 870.4240 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 12, 2025. The decision came 212 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: K240934 (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);).

Questions & Answers

What did FDA clear under K252541?

K252541 is the FDA 510(k) for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W, submitted by Spectrum Medical S.R.L.. FDA's decision date was Mar 12, 2026, under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass).

Who makes the Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

Spectrum Medical S.R.L., based in Mirandola, is the applicant of record for K252541.

How long did the K252541 review take?

FDA received the submission on Aug 12, 2025 and issued its decision on Mar 12, 2026, 212 days later.

← All decisions in March 2026

Sources