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FDA 510(k)

Cleerly Plaque

K-Number: K261210 · 2026-07-29

ApplicantCleerly, Inc.
Decision Date2026-07-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cleerly Plaque is the device name listed in this FDA 510(k) record. The listed applicant is Cleerly, Inc.. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K261210. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleerly Plaque?

Cleerly Plaque is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Cleerly, Inc.. The 510(k) number is K261210.

When did Cleerly Plaque receive FDA 510(k) clearance?

Cleerly Plaque received FDA 510(k) clearance on 2026-07-29, under 510(k) number K261210.

Who is the listed applicant for Cleerly Plaque?

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

What is the FDA product code for Cleerly Plaque?

The FDA product code for Cleerly Plaque is QIH.

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.

NCT06112418A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular EventsRECRUITINGNCT06713239A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CADACTIVE_NOT_RECRUITING

Other records listing Cleerly, 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.

K260588Cleerly LABSK242338Cleerly LABS (v2.0)K231335Cleerly ISCHEMIAK202280Cleerly Labs v2.0K190868Cleerly Labs

Related Devices (Code: QIH)

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.

K253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261349SwiftMRAirs Medical, Inc.K260192DIANAROPCA ApSK254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.K261535Hi-D Imaging 4TAVRHi-D Imaging AG

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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