K254305
- 510(k) number
- K254305
- Device name
- BAROguard Donor Lung Preservation System
- Applicant
- Paragonix Technologies, Inc. MA · US
- Product code
- KDN — System, Perfusion, Kidney
- Decision date
- 2026-01-30
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K254305
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.