KDN — System, Perfusion, Kidney Class II
FDA product code KDN covers "System, Perfusion, Kidney", a Class II medical device regulated under 21 CFR 876.5880. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDN
- Device Class
- Class II
- Regulation Number
- 876.5880
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260456 | traferox technologies | VI°Port Liver Preservation System | June 1, 2026 |
| K254305 | paragonix technologies | BAROguard Donor Lung Preservation System | January 30, 2026 |
| K243618 | bridge to life | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | June 17, 2025 |
| K243870 | traferox technologies | X°Port Lung Preservation System; X°Port Lung Preservation Solution | May 1, 2025 |
| K243998 | institut geroges lopez | DCX Disposable Cassette (DCX) | April 25, 2025 |
| K243384 | bridge to life | Belzer UW® Cold Storage Solution (BTLBUW-001) | March 31, 2025 |
| K243840 | bridge to life | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | March 26, 2025 |
| K240650 | traferox technologies | LungProtect | November 26, 2024 |
| K234060 | paragonix technologies | KIDNEYvault Portable Renal Perfusion System | October 23, 2024 |
| K230193 | s.a.l.f | Servator P Plus SALF Solution | September 21, 2023 |
| K223874 | paragonix technologies | BAROguard | August 15, 2023 |
| K211333 | xvivo perfusion | KIDNEY ASSIST-transport | January 20, 2022 |
| K211224 | institut georges lopez | RM4 Control Unit | October 15, 2021 |
| K202652 | s.a.l.f | Servator P SALF Solution with THAM | August 19, 2021 |
| K203262 | bridge to life | Cannula for Organ Perfusion | July 1, 2021 |
| K201048 | paragonix technologies | SherpaPak Pediatric Liver Transport System | July 2, 2020 |
| K192869 | pragonix technologies | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | January 16, 2020 |
| K191440 | paragonix technologies | Paragonix SherpaPak Pancreas Transport System | December 20, 2019 |
| K191006 | bridge to life | EasiSlush | September 24, 2019 |
| K180481 | s.a.l.f | Servator B SALF Solution | June 29, 2018 |