Panels › Gastroenterology, Urology › Product code KDN · Class 2
System, Perfusion, Kidney
Regulation 876.5880
3510(k)s in 12 months (44 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in KDN
| Company | 510(k)s | Recalls |
|---|---|---|
| Paragonix Technologies | 7 | 1 |
| Preservation Solutions, Inc. | 5 | 2 |
| Bridge TO Life | 5 | 1 |
| Organ Recovery Systems, Inc. | 3 | 1 |
| Xvivo Perfusion AB | 4 | 0 |
| S.A.L.F. Spa | 3 | 0 |
| Traferox Technologies, Inc. | 3 | 0 |
| Waters Instruments, Inc. | 2 | 0 |
| Waters Medical Systems, LLC | 1 | 1 |
| Advanced Equipment Development, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Paragonix Technologies Inc. Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System
REF# PRGNX-8008-001 Open, Classified |
KDN | K234060 |
| Jul 22, 2025 | Bridge to Life Ltd Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250 Open, Classified |
KDN | K191006 |
| Mar 21, 2022 | Waters Medical Systems LLC WAVES WCM Kidney Cassette Module Terminated |
KDN | K111521 |
| Jan 30, 2020 | Organ Recovery Systems, Inc. LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and tr Terminated |
KDN | K021362 |
| Feb 26, 2018 | Preservation Solutions, Inc. Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002.
Intended for the hypothermic flushing and Terminated |
KDN | K073693 |
| Nov 22, 2010 | Preservation Solutions Inc Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., El Terminated |
KDN | K073693 |
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