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FDA 510(k)

Cleerly LABS

K-Number: K260588 · 2026-07-29

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

Device Summary

Cleerly LABS 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 K260588. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleerly LABS?

Cleerly LABS 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 K260588.

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

Cleerly LABS received FDA 510(k) clearance on 2026-07-29, under 510(k) number K260588.

Who is the listed applicant for Cleerly LABS?

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 LABS?

The FDA product code for Cleerly LABS is LLZ.

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.

K261210Cleerly PlaqueK242338Cleerly LABS (v2.0)K231335Cleerly ISCHEMIAK202280Cleerly Labs v2.0K190868Cleerly Labs

Related Devices (Code: LLZ)

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.

K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.K260500ResolutionMDResolutionMD, Inc.K262120Avara ViewerAvara SoftwareK2538993D-AnywhereProvect.AI

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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