Product code KDL
- Device name
- Set, Perfusion, Kidney, Disposable
- 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
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025-01-24 |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022-06-14 |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022-06-14 |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021-12-20 |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020-04-24 |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags | S.A.L.F. Spa | 2017-10-20 |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Waters Medical Systems, LLC | 2013-08-16 |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Waters Medical Systems, LLC | 2013-06-14 |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | 2010-03-11 |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2005-02-28 |
| K020924 | CUSTODIOL HTK SOLUTION | Dr. Franz Kohler Chemie GmbH | 2003-01-06 |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Cobe Renal Care, Inc. | 1997-09-25 |
| K944866 | VIASPAN (BELZER UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | The DU Pont Co. | 1990-03-20 |
| K891239 | MOP CATHETER | Bivona Medical Technologies | 1989-11-28 |
| K883782 | BELZER UW-CSS | Du Pont Critical Care | 1989-04-20 |
| K884609 | EURO-COLLINS SOLUTION SETS | Fresenius USA, Inc. | 1989-01-26 |
| K780470 | H.P. MEDICAL GRADE SILICONE TUBING | Dow Corning Corp. Healthcare Industries Materials | 1978-04-27 |
| K760922 | PERFUSION TUBING SET | Shiley, Inc. | 1976-11-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08052742104401 | Servator H SALF Solution | S.A.L.F. SPA LABORATORIO FARMACOLOGICO | 2026-05-26 |
| 40331330010000 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 40331330020009 | Custodiol | Dr. Franz Köhler Chemie GmbH | 2025-09-19 |
| 00198715358155 | Belzer UW Cold Storage Solution | Bridge To Life Ltd. | 2025-06-17 |
| 00199284590434 | Belzer UW Cold Storage Solution | Bridge To Life Ltd. | 2025-06-17 |
| 00199284914773 | Belzer UW Cold Storage Solution | Bridge To Life Ltd. | 2025-06-17 |
| 13700911900652 | PARAGON-W (UW solution) | INSTITUT GEORGES LOPEZ | 2023-12-22 |
| 13700911900669 | PARAGON-W (UW solution) | INSTITUT GEORGES LOPEZ | 2023-12-22 |
| 04033133420007 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2023-07-03 |
| 13700911900591 | Waters IGL Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2023-05-24 |
| 13700911900607 | Waters IGL Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2023-05-24 |
| 13700911900614 | Waters IGL Pulsatile Perfusion Solution | INSTITUT GEORGES LOPEZ | 2023-05-24 |
| 13700911900492 | PERF-GEN Pulsatile Perfusion Solution | INSTITUT GEORGES LOPEZ | 2022-07-27 |
| 13700911900522 | BEL-GEN Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2022-07-21 |
| 13700911900119 | BEL-GEN Cold Storage Solution | INSTITUT GEORGES LOPEZ | 2022-01-31 |
| 04033133611016 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-08-08 |
| 04033133105003 | Custodiol(R) | Dr. Franz Köhler Chemie GmbH | 2019-05-09 |
| 00815045020339 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020568 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020476 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020452 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020438 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020216 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020322 | SPS-1® (UW Solution) | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020315 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020308 | SPS-1® (UW Solution) | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020285 | SPS-1® (UW Solution) | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020278 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020254 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |
| 00815045020230 | LifePort® Kidney Transporter | ORGAN RECOVERY SYSTEMS, INC. | 2017-10-16 |