BAROguard Donor Lung Preservation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K254305 FDA 510(k)
- FDA Product Code
- KDN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BAROguard Donor Lung Preservation System is a hypothermic preservation system designed to securely transport donor lungs. It is equipped to automatically calibrate the airway pressure of donor lungs during transportation.
This device is supplied by Paragonix Technologies, Inc. and is authorized under FDA 510K and MDR regulations. It is a Class II device with product code KDN and is intended for use in gastroenterology and urology applications.
Frequently asked questions
What is the BAROguard Donor Lung Preservation System used for?
The BAROguard Donor Lung Preservation System is designed to securely transport donor lungs while maintaining hypothermic conditions and automatically calibrating airway pressure during transportation.
How is the BAROguard Donor Lung Preservation System supplied?
The device is supplied by Paragonix Technologies, Inc. and is available as a Class II medical device with product code KDN.
What are the storage requirements for the BAROguard Donor Lung Preservation System?
The device data does not specify storage requirements, so users should consult the manufacturer's instructions for proper storage conditions.
Is the BAROguard Donor Lung Preservation System single-use or reusable?
The device data does not indicate whether the system is single-use or reusable, so users should refer to the manufacturer's guidelines for proper usage instructions.
What regulatory approvals does the BAROguard Donor Lung Preservation System have?
The device is authorized under FDA 510K and MDR regulations, with a decision code of SESE indicating it is substantially equivalent to other devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BAROguard Advanced Lung Preservation System | Paragonix, Paragonix Technologies Announces Nationwide Commercial Availability of ..., Paragonix Technologies Announces Nationwide Commercial Availability of ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K254305 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (2)
- FDA 510(k) K254305 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026