TorEx Lung Perfusion System
FDA premarket approval P250025 · decided 2026-07-15
Approval details
- PMA number
- P250025
- Trade name
- TorEx Lung Perfusion System
- Generic name
- Normothermic preservation system for transplantation of initially unacceptable donor lungs
- Applicant
- Traferox Technologies, Inc.
- Date received
- 2025-07-07
- Decision date
- 2026-07-15
- Days to decision
- 373 days
- Decision code
- APPR
- Product code
- PHO
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Mississauga
- Statement
- The TorEx Lung Perfusion System is indicated for use in continuous normothermic machine perfusion of donor lungs, initially deemed unsuitable for transplantation, during which time the ex vivo function of the lungs can be reassessed for transplantation in adults. The TorEx Lung Perfusion System includes a mobile cart with embedded software, single-use sterile Organ Chamber and Cannulae set and is used with TorEx Lung Perfusate solution to perform ex vivo lung perfusion for up to 6 hours.Note: Th
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VI°Port™ Liver Preservation System (K260456) | Traferox Technologies, Inc. | 2026-06-01 |
| X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870) | Traferox Technologies, Inc. | 2025-05-01 |
| LungProtect (K240650) | Traferox Technologies, Inc. | 2024-11-26 |