Cleared Traditional

K234060 - KIDNEYvault Portable Renal Perfusion System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234060 · Paragonix Technologies · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
306d
Days
Class 2
Risk

K234060 is an FDA 510(k) clearance for the KIDNEYvault Portable Renal Perfusion System. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Paragonix Technologies (Waltham, US). The FDA issued a Cleared decision on October 23, 2024 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Paragonix Technologies devices

Submission Details

510(k) Number K234060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date October 23, 2024
Days to Decision 306 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 130d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDN System, Perfusion, Kidney
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDN System, Perfusion, Kidney

All 41
Devices cleared under the same product code (KDN) and FDA review panel - the closest regulatory comparables to K234060.
BAROguard Donor Lung Preservation System
K254305 · Paragonix Technologies, Inc. · Jan 2026
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
K243618 · Bridge TO Life · Jun 2025
X°Port Lung Preservation System
K243870 · Traferox Technologies, Inc. · May 2025
DCX Disposable Cassette (DCX)
K243998 · Institut Geroges Lopez · Apr 2025
Belzer UW® Cold Storage Solution (BTLBUW-001)
K243384 · Bridge TO Life · Mar 2025
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
K243840 · Bridge TO Life · Mar 2025