KDN
- Product code
- KDN
- Device name
- System, Perfusion, Kidney
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5880
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 44 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261644 | 2026-07-23 | Xvivo Perfusion AB | Perfadex Plus | |
| K260456 | 2026-06-01 | Traferox Technologies, Inc. | VI°Port Liver Preservation System | |
| K254305 | 2026-01-30 | Paragonix Technologies, Inc. | BAROguard Donor Lung Preservation System | — |
| K243618 | 2025-06-17 | Bridge TO Life | EasiSlush® Sodium Chloride Solution for Sterile Slus… | |
| K243870 | 2025-05-01 | Traferox Technologies, Inc. | X°Port Lung Preservation System; X°Port Lung Preserv… | |
| K243998 | 2025-04-25 | Institut Geroges Lopez | DCX Disposable Cassette (DCX) | |
| K243384 | 2025-03-31 | Bridge TO Life | Belzer UW® Cold Storage Solution (BTLBUW-001) | |
| K243840 | 2025-03-26 | Bridge TO Life | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-00… | |
| K240650 | 2024-11-26 | Traferox Technologies, Inc. | LungProtect | |
| K234060 | 2024-10-23 | Paragonix Technologies | KIDNEYvault Portable Renal Perfusion System | FDA |
| K230193 | 2023-09-21 | S.A.L.F. Spa | Servator P Plus SALF Solution |
Official FDA classification page: KDN
Classification and pathway per current FDA publications. Data from openFDA (CC0).