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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 / February 2026 / K252676

510(k) cleared

The Circadia C300 System (C300)

Circadia Health, Inc. · Feb 3, 2026 · K252676

FDA cleared the The Circadia C300 System (C300) from Circadia Health, Inc. on Feb 3, 2026 under K252676, a traditional 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 Aug 25, 2025. The decision came 162 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Circadia Health, Inc. has one other decision in the tracker over the last 12 months: K261286 (The Circadia C300 System (C300)).

Questions & Answers

What did FDA clear under K252676?

K252676 is the FDA 510(k) for The Circadia C300 System (C300), submitted by Circadia Health, Inc.. FDA's decision date was Feb 3, 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 K252676.

How long did the K252676 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Feb 3, 2026, 162 days later.

← All decisions in February 2026

Sources