# Oridion, Ltd.

- Location (FDA's records): Needham, MA
- FDA decisions: 1 (2004–2004): 1 510(k) clearance
- Product codes: CCK (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 4 (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
- Spegas Industries, Ltd.: 1 (https://510kreport.com/company/spegas-industries)

## Firms that cite its devices most
- Invivo Corporation: 2 (https://510kreport.com/company/invivo)
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)

## Its most-cited devices
- K040011: Polaris 2004 Capnograph (2004), cited by 4

## Recent decisions
- K040011: Polaris 2004 Capnograph (May 13, 2004)

Source page: https://510kreport.com/company/oridion