Data / Medical devices / United States / Bridge to Life Ltd
Bridge to Life Ltd: FDA-registered device maker in Duluth, GA, United States, 6 510(k) clearances
Bridge to Life Ltd is registered with the FDA (registration 3031884833) in Duluth, GA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031884833
- Address
- 3300 Breckinridge Blvd., Suite 200, Duluth, GA, United States, 30096
- Owner or operator
- Bridge to Life Ltd. (10038889)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 31, 2019
- Registered through
- 2026
- Brand names listed
- Belzer MPS (UW Machine Perfusion Solution), Belzer UW® Cold Storage Solution, Cannula for Organ Perfusion, EasiSlush, VitaSmart Hypothermic Oxygenated Perfusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | SGY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Set, Perfusion, Kidney, Disposable | KDL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Perfusion, Kidney | KDN | 2 | 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 |
|---|---|---|---|---|---|---|
| January 15, 2026 | DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | SGY | Unknown | Bridge TO Life, Ltd. | accessdata.fda.gov |
| June 17, 2025 | K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | KDN | Substantially Equivalent | Bridge TO Life | accessdata.fda.gov |
| March 31, 2025 | K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | KDN | Substantially Equivalent | Bridge TO Life | accessdata.fda.gov |
| March 26, 2025 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | KDN | Substantially Equivalent | Bridge TO Life | accessdata.fda.gov |
| July 1, 2021 | K203262 | Cannula for Organ Perfusion | KDN | Substantially Equivalent | Bridge TO Life, Ltd. | accessdata.fda.gov |
| September 24, 2019 | K191006 | EasiSlush | KDN | Substantially Equivalent | Bridge TO Life, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Perfusion, Kidney, Disposable
- All makers of System, Perfusion, Kidney
- All makers of System And Accessories, Isolated Heart, Transport And Preservation
- All makers of Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Updated January 15, 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.