# Pulmodyne

- Location (FDA's records): Bonita Springs, FL
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: BYE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (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
- Caradyne, Ltd.: 1 (https://510kreport.com/company/caradyne)

## Firms that cite its devices most
- Smiths Medical International, Ltd.: 1 (https://510kreport.com/company/smiths-medical-international)
- Sen MU Technology Co., Ltd.: 1 (https://510kreport.com/company/sen-mu-technology)

## Its most-cited devices
- K080256: Pulmodyne CHF Flow Generator System (2008), cited by 2

## Recent decisions
- K080256: Pulmodyne CHF Flow Generator System (May 9, 2008)

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