# Caristo Diagnostics, Ltd.

- Location (FDA's records): Oxford, GB
- FDA decisions: 3 (2020–2026): 2 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Caristo Diagnostics , Ltd. (2); Caristo Diagnostics (1)
- Product codes: LLZ (2), SIU (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terarecon,Inc.: 1 (https://510kreport.com/company/terarecon)
- Cedars-Sinai Medical Center: Aim: 1 (https://510kreport.com/company/cedars-sinai-medical-center-aim)

## Firms that cite its devices most
- Artrya Limited: 1 (https://510kreport.com/company/artrya)

## Its most-cited devices
- K242240: CaRi-Plaque (2025), cited by 1

## Recent decisions
- DEN250042: CaRi-Heart (Jul 28, 2026)
- K242240: CaRi-Plaque (Feb 20, 2025)
- K200274: CariCloud (May 21, 2020)

Source page: https://510kreport.com/company/caristo-diagnostics