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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 / K252589

510(k) cleared

Corvair Monza

AliveCor, Inc. · Jan 9, 2026 · K252589

FDA cleared the Corvair Monza from AliveCor, Inc. on Jan 9, 2026 under K252589, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 15, 2025. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K252589?

K252589 is the FDA 510(k) for Corvair Monza, submitted by AliveCor, Inc.. FDA's decision date was Jan 9, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Corvair Monza?

AliveCor, Inc., based in Mountain View, CA, is the applicant of record for K252589.

How long did the K252589 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Jan 9, 2026, 147 days later.

← All decisions in January 2026