# CADDIE (K260133): 510(k) cleared for Odin Medical Limited

**Predicate Speed & CAPA Advisory Opportunity Score:** 47/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260133 |
| Device | CADDIE |
| Applicant | Odin Medical Limited |
| Specialty / panel | Gastroenterology, Urology |
| Product code | QNP |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-01-16 |
| Decision date | 2026-09-12 |
| Review time (days) | 239 |
| Third-party review | No |
| Applicant location | London, GB |

## Why this score
- 239-day review, longer than typical.
- Special 510(k): a modification of an existing device.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260133). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.