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FDA 510(k)

CaloPix

K-Number: K250414 · 2025-05-14

ApplicantTribun Health
Decision Date2025-05-14
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

CaloPix is the device name listed in this FDA 510(k) record. The listed applicant is Tribun Health. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250414. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CaloPix?

CaloPix is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Tribun Health. The 510(k) number is K250414.

When did CaloPix receive FDA 510(k) clearance?

CaloPix received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250414.

Who is the listed applicant for CaloPix?

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

What is the FDA product code for CaloPix?

The FDA product code for CaloPix is QKQ.

Related Devices (Code: QKQ)

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.

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLCK243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation

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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