WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260133

510(k) cleared

CADDIE

Odin Medical Limited · Sep 12, 2026 · K260133

FDA cleared the CADDIE from Odin Medical Limited on Sep 12, 2026 under K260133, 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 Jan 16, 2026. The decision came 239 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K260133?

K260133 is the FDA 510(k) for CADDIE, submitted by Odin Medical Limited. FDA's decision date was Sep 12, 2026, 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 K260133.

How long did the K260133 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Sep 12, 2026, 239 days later.

← All decisions in September 2026