Data / Medical devices / Canada / Traferox Technologies Inc.
Traferox Technologies Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 4 510(k) clearances and 1 PMA approval
Traferox Technologies Inc. is registered with the FDA (registration 3027669473) in Mississauga Ontario, Canada. It lists 3 device types. The FDA files 4 510(k) clearances and 1 PMA approval under its listings, the newest dated September 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027669473
- Address
- 3505 Laird Rd, Unit 16, Mississauga Ontario, Canada, L5L 5Y7
- Owner or operator
- Traferox Technologies Inc. (10093353)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 5, 2025
- Registered through
- 2026
- Brand names listed
- LungProtect, TorEx Lung Perfusion System; TorEx Lung Perfusate, VI°Port Liver Preservation System, X°Port Heart Preservation System, X°Port Lung Preservation System; X°Port Lung Preservation Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | PHO | 3 | Manufacturer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Manufacturer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261913 | X°Port Heart Preservation System | MSB | Substantially Equivalent | Traferox Technologies, Inc. | accessdata.fda.gov |
| June 1, 2026 | K260456 | VI°Port Liver Preservation System | KDN | Substantially Equivalent | Traferox Technologies, Inc. | accessdata.fda.gov |
| May 1, 2025 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | KDN | Substantially Equivalent | Traferox Technologies, Inc. | accessdata.fda.gov |
| November 26, 2024 | K240650 | LungProtect | KDN | Substantially Equivalent | Traferox Technologies, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 15, 2026 | P250025 | TorEx Lung Perfusion System | PHO | 0 | July 15, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of System, Perfusion, Kidney
- All makers of Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.