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FDA 510(k)

CADDIE

K-Number: K252586 · 2025-09-12

Decision Date2025-09-12
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CADDIE is the device name listed in this FDA 510(k) record. The listed applicant is Odin Medical Limited. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252586. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADDIE?

CADDIE is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Odin Medical Limited. The 510(k) number is K252586.

When did CADDIE receive FDA 510(k) clearance?

CADDIE received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252586.

Who is the listed applicant for CADDIE?

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

What is the FDA product code for CADDIE?

The FDA product code for CADDIE is QNP.

Other records listing Odin Medical Limited 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.

Related Devices (Code: QNP)

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.

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.