KDN · System, Perfusion, Kidney
Gastroenterology, Urology · 21 CFR 876.5880 · Class 2
Overview
| Product Code | KDN |
|---|---|
| Device Name | System, Perfusion, Kidney |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | Jan 30, 2026 | SESE |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life | Jun 17, 2025 | SESE |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | May 1, 2025 | SESE |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | Apr 25, 2025 | SESE |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | Mar 31, 2025 | SESE |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | Mar 26, 2025 | SESE |
| K240650 | LungProtect | Traferox Technologies, Inc. | Nov 26, 2024 | SESE |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | Oct 23, 2024 | SESE |
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | Sep 21, 2023 | SESE |
| K223874 | BAROguard | Paragonix Technologies | Aug 15, 2023 | SESE |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | Jan 20, 2022 | SESE |
| K211224 | RM4 Control Unit | Institut Georges Lopez | Oct 15, 2021 | SESE |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | Aug 19, 2021 | SESE |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | Jul 1, 2021 | SESE |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | Jul 2, 2020 | SESE |
| K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | Pragonix Technologies | Jan 16, 2020 | SESK |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Paragonix Technologies | Dec 20, 2019 | SESE |
| K191006 | EasiSlush | Bridge TO Life, Ltd. | Sep 24, 2019 | SESE |
| K180481 | Servator B SALF Solution | S.A.L.F. Spa | Jun 29, 2018 | SESE |
| K170826 | Perfadex Plus | Xvivo Perfusion AB | Jun 22, 2018 | SESE |
Top Applicants
- Preservation Solutions, Inc. — 5 clearances
- Paragonix Technologies — 4 clearances
- Bridge TO Life — 3 clearances
- Organ Recovery Systems, Inc. — 3 clearances
- Paragonix Technologies, Inc. — 3 clearances
