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FDA 510(k)

The Circadia CX00 System (CX00)

K-Number: K262447 · 2026-10-15

ApplicantCircadia Health, Inc.
Decision Date2026-10-15
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The Circadia CX00 System (CX00) is the device name listed in this FDA 510(k) record. The listed applicant is Circadia Health, Inc.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K262447. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Circadia CX00 System (CX00)?

The Circadia CX00 System (CX00) is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Circadia Health, Inc.. The 510(k) number is K262447.

When did The Circadia CX00 System (CX00) receive FDA 510(k) clearance?

The Circadia CX00 System (CX00) received FDA 510(k) clearance on 2026-10-15, under 510(k) number K262447.

Who is the listed applicant for The Circadia CX00 System (CX00)?

The FDA 510(k) record lists Circadia Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Circadia CX00 System (CX00)?

The FDA product code for The Circadia CX00 System (CX00) is DRT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Circadia Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261286The Circadia C300 System (C300)K252676The Circadia C300 System (C300)

Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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