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The Tracker / October 2026 / K262447

510(k) cleared

The Circadia CX00 System (CX00)

Circadia Health, Inc. · Oct 15, 2026 · K262447

FDA cleared the The Circadia CX00 System (CX00) from Circadia Health, Inc. on Oct 15, 2026 under K262447, 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 Jul 16, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Circadia Health, Inc. has 2 other decisions in the tracker over the last 12 months: K261286 (The Circadia C300 System (C300)), K252676 (The Circadia C300 System (C300)).

Questions & Answers

What did FDA clear under K262447?

K262447 is the FDA 510(k) for The Circadia CX00 System (CX00), submitted by Circadia Health, Inc.. FDA's decision date was Oct 15, 2026, under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)).

Who makes the The Circadia CX00 System (CX00)?

Circadia Health, Inc., based in El Segundo, CA, is the applicant of record for K262447.

How long did the K262447 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Oct 15, 2026, 91 days later.

← All decisions in October 2026

Sources