FDA Product Code
FDA Product Code KDN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5880
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026-07-23 | Traditional | PDF ↗ |
| K260456 | VI°Port Liver Preservation System | Traferox Technologies, Inc. | 2026-06-01 | Traditional | PDF ↗ |
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | 2026-01-30 | Special | PDF ↗ |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life | 2025-06-17 | Traditional | PDF ↗ |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025-05-01 | Traditional | PDF ↗ |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | 2025-04-25 | Traditional | PDF ↗ |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025-03-31 | Traditional | PDF ↗ |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025-03-26 | Traditional | PDF ↗ |
| K240650 | LungProtect | Traferox Technologies, Inc. | 2024-11-26 | Traditional | PDF ↗ |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | 2024-10-23 | Traditional | PDF ↗ |
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023-09-21 | Traditional | PDF ↗ |
| K223874 | BAROguard | Paragonix Technologies | 2023-08-15 | Traditional | PDF ↗ |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | 2022-01-20 | Traditional | PDF ↗ |
| K211224 | RM4 Control Unit | Institut Georges Lopez | 2021-10-15 | Traditional | PDF ↗ |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | 2021-08-19 | Traditional | PDF ↗ |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021-07-01 | Traditional | PDF ↗ |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | 2020-07-02 | Traditional | PDF ↗ |
| K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | Pragonix Technologies | 2020-01-16 | Traditional | PDF ↗ |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies | 2019-12-20 | Traditional | PDF ↗ |
| K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019-09-24 | Traditional | PDF ↗ |
| K180481 | Servator B SALF Solution | S.A.L.F. Spa | 2018-06-29 | Traditional | PDF ↗ |
| K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018-06-22 | Traditional | PDF ↗ |
| K153384 | Low Potassium Dextran Solution with Tris Diluent | United Therapeutics Corporation | 2016-02-19 | Traditional | PDF ↗ |
| K151728 | CoStorSol plus G | Preservation Solutions, Inc. | 2015-09-18 | Traditional | PDF ↗ |
| K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014-11-25 | Special | PDF ↗ |
| K133694 | SHERPA PAK TRANSPORTER | Paragonix Technologies, Inc. | 2014-05-23 | Traditional | PDF ↗ |
| K111521 | WAVES | Waters Medical Systems, LLC | 2012-02-16 | Traditional | PDF ↗ |
| K091989 | PERFADEX AND PERFADEX WITH THAM | Xvivo Perfusion AB | 2010-10-01 | Special | PDF ↗ |
| K091245 | COSTORSOL | Preservation Solutions, Inc. | 2009-06-17 | Traditional | PDF ↗ |
| K083453 | COSTORSOL | Preservation Solutions, Inc. | 2009-01-21 | Traditional | PDF ↗ |
| K080432 | MAPERSOL | Preservation Solutions, Inc. | 2008-08-08 | Traditional | PDF ↗ |
| K073693 | COSTORSOL | Preservation Solutions, Inc. | 2008-07-03 | Traditional | PDF ↗ |
| K042224 | RM3 RENAL PRESERVATION SYSTEM | Waters Instruments, Inc. | 2004-10-22 | Special | PDF ↗ |
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | Organ Recovery Systems, Inc. | 2003-07-31 | Traditional | PDF ↗ |
| K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | Organ Recovery Systems, Inc. | 2002-10-21 | Special | PDF ↗ |
| K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION | Organ Recovery Systems, Inc. | 2002-01-25 | Traditional | PDF ↗ |
| K992209 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 1999-12-10 | Traditional | PDF ↗ |
| K990229 | HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 | Justec Medical Products, Inc. | 1999-11-04 | Traditional | PDF ↗ |
| K972066 | BELZER-MPS | Trans-Med Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | Waters Instruments, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K911587 | K-SOL(TM) | Alcon Laboratories | 1991-11-01 | Traditional | PDF ↗ |
| K864140 | KIDNEY PERFUSION MACHINE | Advanced Equipment Development, Inc. | 1987-03-05 | Traditional | PDF ↗ |
| K840687 | KIDNEY TRANSPLANT CATHETER | Warne Surgical Products, Ltd. | 1984-06-07 | Traditional | PDF ↗ |
| K830994 | REDOX CONTROLLER | St. Louis Univ. Medical Center | 1983-05-27 | Traditional | PDF ↗ |
Product code KDN · Class II · Gastroenterology, Urology. Data: openFDA.