Data / Medical devices / United Kingdom / Odin Medical Limited
Odin Medical Limited: FDA-registered device maker in London London, City of, United Kingdom, 3 510(k) clearances
Odin Medical Limited is registered with the FDA (registration 3031983124) in London London, City of, United Kingdom. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031983124
- Address
- 74 Rivington Street, London London, City of, United Kingdom, EC2A 3AY
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- November 5, 2024
- Registered through
- 2027
- Brand names listed
- CADDIE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointesinal Lesion Software Detection System | QNP | 2 | Manufacturer | accessdata.fda.gov |
| Software For Endoscopy Procedure Metrics | SBX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2026 | K260133 | CADDIE | QNP | Substantially Equivalent | Odin Medical Limited | accessdata.fda.gov |
| September 12, 2025 | K252586 | CADDIE | QNP | Substantially Equivalent | Odin Medical Limited | accessdata.fda.gov |
| July 24, 2024 | K240044 | CADDIE | QNP | Substantially Equivalent | Odin Medical Limited | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.