FDA 510(k) Applications for Medical Device Product Code "KDN"
(System, Perfusion, Kidney)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243840 | Bridge to Life | Belzer MPS« (UW Machine Perfusion Solution) (BMPS-001) | 03/26/2025 |
| K243384 | Bridge to Life | Belzer UW« Cold Storage Solution (BTLBUW-001) | 03/31/2025 |
| K243618 | Bridge to Life | EasiSlush« Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | 06/17/2025 |
| K203262 | Bridge to Life Ltd. | Cannula for Organ Perfusion | 07/01/2021 |
| K191006 | Bridge to Life Ltd. | EasiSlush | 09/24/2019 |
| K992209 | DR. FRANZ KOHLER CHEMIE GMBH | CUSTODIOL | 12/10/1999 |
| K211224 | Institut Georges Lopez | RM4 Control Unit | 10/15/2021 |
| K243998 | Institut Geroges Lopez | DCX Disposable Cassette (DCX) | 04/25/2025 |
| K990229 | JUSTEC MEDICAL PRODUCTS, INC. | HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 | 11/04/1999 |
| K013575 | ORGAN RECOVERY SYSTEMS, INC. | KPS-I, THE KIDNEY PERFUSION SOLUTION | 01/25/2002 |
| K021362 | ORGAN RECOVERY SYSTEMS, INC. | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | 07/31/2003 |
| K022391 | ORGAN RECOVERY SYSTEMS, INC. | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | 10/21/2002 |
| K223874 | Paragonix Technologies | BAROguard | 08/15/2023 |
| K234060 | Paragonix Technologies | KIDNEYvault Portable Renal Perfusion System | 10/23/2024 |
| K191440 | Paragonix Technologies | Paragonix SherpaPak Pancreas Transport System | 12/20/2019 |
| K201048 | Paragonix Technologies | SherpaPak Pediatric Liver Transport System | 07/02/2020 |
| K143054 | PARAGONIX TECHNOLOGIES, INC. | Sherpa Pak Kidney Transport System | 11/25/2014 |
| K133694 | PARAGONIX TECHNOLOGIES, INC. | SHERPA PAK TRANSPORTER | 05/23/2014 |
| K192869 | Pragonix Technologies | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | 01/16/2020 |
| K073693 | PRESERVATION SOLUTIONS, INC. | COSTORSOL | 07/03/2008 |
| K083453 | PRESERVATION SOLUTIONS, INC. | COSTORSOL | 01/21/2009 |
| K091245 | PRESERVATION SOLUTIONS, INC. | COSTORSOL | 06/17/2009 |
| K151728 | PRESERVATION SOLUTIONS, INC. | CoStorSol plus G | 09/18/2015 |
| K080432 | PRESERVATION SOLUTIONS, INC. | MAPERSOL | 08/08/2008 |
| K180481 | S.A.L.F. spa | Servator B SALF Solution | 06/29/2018 |
| K230193 | S.A.L.F. spa | Servator P Plus SALF Solution | 09/21/2023 |
| K202652 | S.A.L.F. spa | Servator P SALF Solution with THAM | 08/19/2021 |
| K240650 | Traferox Technologies Inc. | LungProtect | 11/26/2024 |
| K243870 | Traferox Technologies Inc. | X░Port Lung Preservation System; X░Port Lung Preservation Solution | 05/01/2025 |
| K972066 | TRANS-MED CORP. | BELZER-MPS | 11/26/1997 |
| K153384 | United Therapeutics Corporation | Low Potassium Dextran Solution with Tris Diluent | 02/19/2016 |
| K042224 | WATERS INSTRUMENTS, INC. | RM3 RENAL PRESERVATION SYSTEM | 10/22/2004 |
| K971571 | WATERS INSTRUMENTS, INC. | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | 07/29/1997 |
| K111521 | WATERS MEDICAL SYSTEMS, LLC | WAVES | 02/16/2012 |
| K211333 | XVIVO Perfusion AB | KIDNEY ASSIST-transport | 01/20/2022 |
| K091989 | XVIVO PERFUSION AB | PERFADEX AND PERFADEX WITH THAM | 10/01/2010 |
| K170826 | XVIVO Perfusion AB | Perfadex Plus | 06/22/2018 |
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