Panels › Gastroenterology, Urology › Product code KDN · Class 2
System, Perfusion, Kidney
Regulation 876.5880
3510(k)s in 12 months (44 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in KDN
| Company | 510(k)s | Recalls |
|---|---|---|
| Paragonix Technologies | 7 | 1 |
| Preservation Solutions, Inc. | 5 | 2 |
| Bridge TO Life | 5 | 1 |
| Organ Recovery Systems, Inc. | 3 | 1 |
| Xvivo Perfusion AB | 4 | 0 |
| S.A.L.F. Spa | 3 | 0 |
| Traferox Technologies, Inc. | 3 | 0 |
| Waters Instruments, Inc. | 2 | 0 |
| Waters Medical Systems, LLC | 1 | 1 |
| Advanced Equipment Development, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2026 | K261644 | Perfadex Plus Xvivo Perfusion AB, SE | KDN |
| Jun 1, 2026 | K260456 | VI°Port Liver Preservation System Traferox Technologies, Inc., CA | KDN |
| Jan 30, 2026 | K254305 | BAROguard Donor Lung Preservation System Paragonix Technologies, Inc. | KDN |
| Jun 17, 2025 | K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) Bridge TO Life | KDN |
| May 1, 2025 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution Traferox Technologies, Inc., CA | KDN |
| Apr 25, 2025 | K243998 | DCX Disposable Cassette (DCX) Institut Geroges Lopez, FR | KDN |
| Mar 31, 2025 | K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) Bridge TO Life | KDN |
| Mar 26, 2025 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) Bridge TO Life | KDN |
| Nov 26, 2024 | K240650 | LungProtect Traferox Technologies, Inc., CA | KDN |
| Oct 23, 2024 | K234060 | KIDNEYvault Portable Renal Perfusion System Paragonix Technologies | KDN |
| Sep 21, 2023 | K230193 | Servator P Plus SALF Solution S.A.L.F. Spa, IT | KDN |
| Aug 15, 2023 | K223874 | BAROguard Paragonix Technologies | KDN |
| Jan 20, 2022 | K211333 | KIDNEY ASSIST-transport Xvivo Perfusion AB, SE | KDN |
| Oct 15, 2021 | K211224 | RM4 Control Unit Institut Georges Lopez, FR | KDN |
| Aug 19, 2021 | K202652 | Servator P SALF Solution with THAM S.A.L.F. Spa, IT | KDN |
| Jul 1, 2021 | K203262 | Cannula for Organ Perfusion Bridge TO Life, Ltd. | KDN |
| Jul 2, 2020 | K201048 | SherpaPak Pediatric Liver Transport System Paragonix Technologies | KDN |
| Jan 16, 2020 | K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System Pragonix Technologies | KDN |
| Dec 20, 2019 | K191440 | Paragonix SherpaPak Pancreas Transport System Paragonix Technologies | KDN |
| Sep 24, 2019 | K191006 | EasiSlush Bridge TO Life, Ltd. | KDN |
| Jun 29, 2018 | K180481 | Servator B SALF Solution S.A.L.F. Spa, IT | KDN |
| Jun 22, 2018 | K170826 | Perfadex Plus Xvivo Perfusion AB, SE | KDN |
| Feb 19, 2016 | K153384 | Low Potassium Dextran Solution with Tris Diluent United Therapeutics Corporation | KDN |
| Sep 18, 2015 | K151728 | CoStorSol plus G Preservation Solutions, Inc. | KDN |
| Nov 25, 2014 | K143054 | Sherpa Pak Kidney Transport System Paragonix Technologies, Inc. | KDN |
| May 23, 2014 | K133694 | SHERPA PAK TRANSPORTER Paragonix Technologies, Inc. | KDN |
| Feb 16, 2012 | K111521 | WAVES Waters Medical Systems, LLC | KDN |
| Oct 1, 2010 | K091989 | PERFADEX AND PERFADEX WITH THAM Xvivo Perfusion AB, SE | KDN |
| Jun 17, 2009 | K091245 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Jan 21, 2009 | K083453 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Aug 8, 2008 | K080432 | MAPERSOL Preservation Solutions, Inc. | KDN |
| Jul 3, 2008 | K073693 | COSTORSOL Preservation Solutions, Inc. | KDN |
| Oct 22, 2004 | K042224 | RM3 RENAL PRESERVATION SYSTEM Waters Instruments, Inc. | KDN |
| Jul 31, 2003 | K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) Organ Recovery Systems, Inc. | KDN |
| Oct 21, 2002 | K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION Organ Recovery Systems, Inc. | KDN |
| Jan 25, 2002 | K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION Organ Recovery Systems, Inc. | KDN |
| Dec 10, 1999 | K992209 | CUSTODIOL Dr. Franz Kohler Chemie GmbH | KDN |
| Nov 4, 1999 | K990229 | HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 Justec Medical Products, Inc. | KDN |
| Nov 26, 1997 | K972066 | BELZER-MPS Trans-Med Corp. | KDN |
| Jul 29, 1997 | K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT Waters Instruments, Inc. | KDN |
| Nov 1, 1991 | K911587 | K-SOL(TM) Alcon Laboratories | KDN |
| Mar 5, 1987 | K864140 | KIDNEY PERFUSION MACHINE Advanced Equipment Development, Inc. | KDN |
| Jun 7, 1984 | K840687 | KIDNEY TRANSPLANT CATHETER Warne Surgical Products, Ltd. | KDN |
| May 27, 1983 | K830994 | REDOX CONTROLLER St. Louis Univ. Medical Center | KDN |
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