FDA 510(k)

The Circadia C300 System (C300)

K-Number: K252676 · 2026-02-03

Decision Date2026-02-03

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

The Circadia C300 System (C300) is a medical device manufactured by Circadia Health, Inc.. It received FDA 510(k) clearance on 2026-02-03 under approval 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. It is manufactured by Circadia Health, Inc.. The 510(k) number is K252676.

When was The Circadia C300 System (C300) approved by the FDA?

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

What company makes The Circadia C300 System (C300)?

The Circadia C300 System (C300) is manufactured by Circadia Health, Inc..

What is the FDA product code for The Circadia C300 System (C300)?

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

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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.