Product code KDN
- Device name
- System, Perfusion, Kidney
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5880
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | 2026-01-30 |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life | 2025-06-17 |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025-05-01 |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | 2025-04-25 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025-03-31 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025-03-26 |
| K240650 | LungProtect | Traferox Technologies, Inc. | 2024-11-26 |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | 2024-10-23 |
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023-09-21 |
| K223874 | BAROguard | Paragonix Technologies | 2023-08-15 |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | 2022-01-20 |
| K211224 | RM4 Control Unit | Institut Georges Lopez | 2021-10-15 |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | 2021-08-19 |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021-07-01 |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | 2020-07-02 |
| K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | Pragonix Technologies | 2020-01-16 |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies | 2019-12-20 |
| K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019-09-24 |
| K180481 | Servator B SALF Solution | S.A.L.F. Spa | 2018-06-29 |
| K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018-06-22 |
| K153384 | Low Potassium Dextran Solution with Tris Diluent | United Therapeutics Corporation | 2016-02-19 |
| K151728 | CoStorSol plus G | Preservation Solutions, Inc. | 2015-09-18 |
| K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014-11-25 |
| K133694 | SHERPA PAK TRANSPORTER | Paragonix Technologies, Inc. | 2014-05-23 |
| K111521 | WAVES | Waters Medical Systems, LLC | 2012-02-16 |
| K091989 | PERFADEX AND PERFADEX WITH THAM | Xvivo Perfusion AB | 2010-10-01 |
| K091245 | COSTORSOL | Preservation Solutions, Inc. | 2009-06-17 |
| K083453 | COSTORSOL | Preservation Solutions, Inc. | 2009-01-21 |
| K080432 | MAPERSOL | Preservation Solutions, Inc. | 2008-08-08 |
| K073693 | COSTORSOL | Preservation Solutions, Inc. | 2008-07-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 13700911901000 | Perfusion Cannula | INSTITUT GEORGES LOPEZ | 2026-05-11 |
| 13700911901017 | Perfusion Cannula | INSTITUT GEORGES LOPEZ | 2026-05-11 |
| 13700911901024 | Perfusion Cannula | INSTITUT GEORGES LOPEZ | 2026-05-11 |
| 40331330020009 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 40331330005006 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 40331330010000 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 00199284914773 | Belzer UW Cold Storage Solution | Bridge To Life Ltd. | 2025-06-17 |
| 00198715358155 | Belzer UW Cold Storage Solution | Bridge To Life Ltd. | 2025-06-17 |
| 13700911901055 | Perfusion Coupler | INSTITUT GEORGES LOPEZ | 2025-05-26 |
| 00850005470038 | PancreasPak | Paragonix Technologies Inc | 2024-09-01 |
| 00850005470045 | PancreasPak | Paragonix Technologies Inc | 2024-09-01 |
| 00850005470052 | PancreasPak | Paragonix Technologies Inc | 2024-09-01 |
| 13700911900669 | PARAGON-W (UW solution) | INSTITUT GEORGES LOPEZ | 2023-12-22 |
| 13700911900652 | PARAGON-W (UW solution) | INSTITUT GEORGES LOPEZ | 2023-12-22 |
| 13700911900607 | Waters IGL Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2023-05-24 |
| 13700911900591 | Waters IGL Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2023-05-24 |
| 13700911900485 | RM4 Kidney Perfusion System | INSTITUT GEORGES LOPEZ | 2023-01-31 |
| 00850005470151 | LUNGguard | Paragonix Technologies Inc | 2022-12-13 |
| 13700911900522 | BEL-GEN Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2022-07-21 |
| 00815045020346 | KPS-1® | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00810805000101 | Belzer MPS (UW Machine Perfusion Solution ) | PRESERVATION SOLUTIONS INC | 2017-04-03 |
| B154W39300050123 | WCM Kit | WATERS MEDICAL SYSTEMS, LLC | 2017-02-12 |
| B154W39300050020 | WAVES/WCM Sterile Drape | WATERS MEDICAL SYSTEMS, LLC | 2017-02-12 |
| 00810805000071 | Belzer UW Cold Storage Solution | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000095 | Belzer MPS (UW Machine Perfusion Solution ) | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000156 | Waters IGL Cold Storage Solution | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000163 | Waters IGL Cold Storage Solution | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000170 | Waters IGL Pulsatile Perfusion Solution | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000026 | Belzer UW Cold Storage Solution | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 00810805000040 | Belzer UW Cold Storage Solution | PRESERVATION SOLUTIONS INC | 2016-10-07 |