Data / Medical devices / United Kingdom / Caristo Diagnostics
Caristo Diagnostics: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 2 510(k) clearances
Caristo Diagnostics is registered with the FDA (registration 3017140520) in Oxford Oxfordshire, United Kingdom. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017140520
- Address
- Caristo Diagnostics New Barclay House, 234 Botley Road, Oxford Oxfordshire, United Kingdom, OX20HP
- Owner or operator
- Caristo Diagnostics (10075378)
- Roles
- Manufacturer
- First device listed
- December 24, 2025
- Registered through
- 2026
- Brand names listed
- CaRi-Heart, CaRi-Plaque
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Predictive Indicator For Long-Term Cardiovascular Outcomes | SIU | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| July 28, 2026 | DEN250042 | CaRi-Heart | SIU | Unknown | Caristo Diagnostics , Ltd. | accessdata.fda.gov |
| February 20, 2025 | K242240 | CaRi-Plaque | LLZ | Substantially Equivalent | Caristo Diagnostics , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 28, 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.