Class Class II
KIDNEYvault Portable Renal Perfusion System (K234060)
Description
KIDNEYvault Portable Renal Perfusion System by Paragonix Technologies, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234060
Clearance Date2024-10-23
Clearance TypeTraditional
Product CodeKDN
Regulation Number876.5880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234060
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. KIDNEYvault Portable Renal Perfusion System (K234060) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | 2022 |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Tra... | Paragonix Technologies, Inc. | 2018 |
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | Organ Recovery Systems, Inc. | 2003 |
Trace the full predicate network for K234060
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.