Cleared Special

BAROguard Donor Lung Preservation System

K254305 · Paragonix Technologies, Inc. · Gastroenterology & Urology
Jan 2026
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K254305 is an FDA 510(k) clearance for the BAROguard Donor Lung Preservation System, a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Paragonix Technologies, Inc. (Waltham, US). The FDA issued a Cleared decision on January 30, 2026, 30 days after receiving the submission on December 31, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number K254305 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2025
Decision Date January 30, 2026
Days to Decision 30 days
Submission Type Special
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

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