LifePort® Kidney Transporter
LifePort® Kidney Transporter Oxygenation Perfusion Circuit
1manufacturer
5catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
Record
| Listed by | Organ Recovery Systems, Inc., United States |
|---|---|
| FDA product code | KDN |
| Device type | System, Perfusion, Kidney |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5880 |
| Establishment | Manufacturer |
| 510(k) | K021362 |
| Record published | 2025-08-14 |
| Record revised | 2025-08-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 40 °C; Storage environment temperature 36 to 104 °F |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LKT201X | In distribution | |
| LKT101P | In distribution | |
| LKT300 | In distribution | |
| LKT201 | In distribution | |
| LKT100P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BAROguard | Paragonix Technologies, Inc. | 7 |
| KidneyVault | Paragonix Technologies, Inc. | 5 |
| KidneyVault Portable Renal Perfusion System | Paragonix Technologies, Inc. | 3 |
| PancreasPak | Paragonix Technologies, Inc. | 3 |
| Perfadex Plus® | Xvivo Perfusion AB | 3 |
| Perfusion Cannula | Institut Georges Lopez | 3 |
| Belzer UW Cold Storage Solution | Bridge to Life Ltd | 3 |
| Belzer UW Cold Storage Solution | Preservation Solutions, Inc. | 3 |
| X°Port Lung Preservation Solution | Traferox Technologies Inc. | 3 |
| LUNGguard | Paragonix Technologies, Inc. | 2 |
| Servator B Salf Solution | S.a.l.f. SPA Laboratorio Farmacologico | 2 |
| Waters IGL Cold Storage Solution | Institut Georges Lopez | 2 |
Showing 12 of 78. All products under System, Perfusion, Kidney
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021362 | 2003-07-31 |
| K022391 | 2002-10-21 |
| K013575 | 2002-01-25 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Organ Recovery Systems, Inc. | 510(k) number | 2020-01-30 | Class II | Reprocessing Controls | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. | 2274 | 2021-09-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.