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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 / April 2026 / K253436

510(k) cleared

c-med0 alpha

Cosinuss GmbH · Apr 30, 2026 · K253436

FDA cleared the c-med0 alpha from Cosinuss GmbH on Apr 30, 2026 under K253436, a traditional 510(k). The device falls under product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 1, 2025. The decision came 211 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 Cosinuss GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253436?

K253436 is the FDA 510(k) for c-med0 alpha, submitted by Cosinuss GmbH. FDA's decision date was Apr 30, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the c-med0 alpha?

Cosinuss GmbH, based in Munich, is the applicant of record for K253436.

How long did the K253436 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Apr 30, 2026, 211 days later.

← All decisions in April 2026