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FDA 510(k)

The Circadia C300 System (C300)

K-Number: K252676 · 2026-02-03

ApplicantCircadia Health, Inc.
Decision Date2026-02-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

The Circadia C300 System (C300) 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 2026-02-03 under 510(k) number K252676. 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 C300 System (C300)?

The Circadia C300 System (C300) is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Circadia Health, Inc.. The 510(k) number is K252676.

When did The Circadia C300 System (C300) receive FDA 510(k) clearance?

The Circadia C300 System (C300) received FDA 510(k) clearance on 2026-02-03, under 510(k) number K252676.

Who is the listed applicant for The Circadia C300 System (C300)?

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 C300 System (C300)?

The FDA product code for The Circadia C300 System (C300) is DRT.

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)

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.

K261286The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd.

Official Source

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

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