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FDA 510(k)

Cleerly LABS (v2.0)

K-Number: K242338 · 2025-03-07

ApplicantCleerly, Inc.
Decision Date2025-03-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cleerly LABS (v2.0) is a medical device manufactured by Cleerly, Inc.. It received FDA 510(k) clearance on 2025-03-07 under approval number K242338. 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 LABS (v2.0)?

Cleerly LABS (v2.0) is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Cleerly, Inc.. The 510(k) number is K242338.

When was Cleerly LABS (v2.0) approved by the FDA?

Cleerly LABS (v2.0) received FDA 510(k) clearance on 2025-03-07, under approval number K242338.

What company makes Cleerly LABS (v2.0)?

Cleerly LABS (v2.0) is manufactured by Cleerly, Inc..

What is the FDA product code for Cleerly LABS (v2.0)?

The FDA product code for Cleerly LABS (v2.0) is QIH.

Other Devices by Cleerly, Inc.

K190868Cleerly Labs K202280Cleerly Labs v2.0 K231335Cleerly ISCHEMIA

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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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