CADDIE— 510(k) K260133
Substantially EquivalentOdin Medical Limited
FDA 510(k) clearance K260133 for CADDIE, Substantially Equivalent on 2026-09-12. Applicant: Odin Medical Limited. Device class: 2.
Summary
CADDIE is computer-aided detection software for GI endoscopy. Its product code, QNP, is the category FDA created for AI that flags possible polyps and other lesions on the live video feed.
Class II under 21 CFR 876.1520, reviewed by the Gastroenterology and Urology panel. Odin Medical filed it as a Special 510(k), meaning a change to a device it already had cleared.
That's what makes the 239-day clock (January 16 to September 12, 2026) odd. Special 510(k)s exist for quick, contained modifications. Eight months points to real questions from FDA, and changes to a detection algorithm tend to draw them. Odin Medical is based in London.
Clearance details
- Applicant
- Odin Medical Limited
- Product code
- Code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- London, GB
Recent devices under product code QNP
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