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The Tracker / September 2025 / K252586

510(k) cleared

CADDIE

Odin Medical Limited · Sep 12, 2025 · K252586

FDA cleared the CADDIE from Odin Medical Limited on Sep 12, 2025 under K252586, a special 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Aug 15, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Odin Medical Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252586?

K252586 is the FDA 510(k) for CADDIE, submitted by Odin Medical Limited. FDA's decision date was Sep 12, 2025, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the CADDIE?

Odin Medical Limited, based in London, is the applicant of record for K252586.

How long did the K252586 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Sep 12, 2025, 28 days later.

← All decisions in September 2025