Cleared Traditional

SherpaPak Pediatric Liver Transport System

K201048 · Paragonix Technologies · Gastroenterology & Urology
Jul 2020
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K201048 is an FDA 510(k) clearance for the SherpaPak Pediatric Liver Transport System, a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on July 2, 2020, 72 days after receiving the submission on April 21, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number K201048 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2020
Decision Date July 02, 2020
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KDN — System, Perfusion, Kidney
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5880

Similar Devices — KDN System, Perfusion, Kidney

All 41
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; X?Port Lung Preservation Solution
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