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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 / May 2026 / K261286

510(k) cleared

The Circadia C300 System (C300)

Circadia Health, Inc. · May 20, 2026 · K261286

FDA cleared the The Circadia C300 System (C300) from Circadia Health, Inc. on May 20, 2026 under K261286, a special 510(k). The device falls under product code DRT, Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 20, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Circadia Health, Inc. has one other decision in the tracker over the last 12 months: K252676 (The Circadia C300 System (C300)).

Questions & Answers

What did FDA clear under K261286?

K261286 is the FDA 510(k) for The Circadia C300 System (C300), submitted by Circadia Health, Inc.. FDA's decision date was May 20, 2026, under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)).

Who makes the The Circadia C300 System (C300)?

Circadia Health, Inc., based in El Segundo, CA, is the applicant of record for K261286.

How long did the K261286 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on May 20, 2026, 30 days later.

← All decisions in May 2026

Sources