Cleared Special

K260133 - CADDIE

K260133 is an FDA 510(k) clearance for CADDIE, manufactured by Odin Medical Limited. The device is a Class 2 Gastroenterology & Urology device with product code QNP cleared through the Special 510(k) pathway after a 239-day FDA review.

K260133 · Odin Medical Limited · Gastroenterology & Urology device
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Sep 2026
Decision
239d
Days
Class 2
Risk

K260133 is an FDA 510(k) clearance for the CADDIE. Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Odin Medical Limited (London, GB). The FDA issued a Cleared decision on September 12, 2026 after a review of 239 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Odin Medical Limited devices

FDA 510(k) Submission Details - K260133

510(k) Number K260133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2026
Decision Date September 12, 2026
Days to Decision 239 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 131d · This submission: 239d
Pathway characteristics
Modification to existing cleared device.

QNP Device Classification - Class 2, Special Controls

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1520
Definition A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QNP Gastrointesinal Lesion Software Detection System

All 22
Devices cleared under the same product code (QNP) and FDA review panel - the closest regulatory comparables to K260133.
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