BAROguard Donor Lung Preservation System— 510(k) K254305

Name: FDA 510(k) clearance K254305
Creator: U.S. Food and Drug Administration
Published: 2026-01-30

Substantially Equivalent

Paragonix Technologies, Inc.

FDA 510(k) clearance K254305 for BAROguard Donor Lung Preservation System, Substantially Equivalent on 2026-01-30. Applicant: Paragonix Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Paragonix Technologies, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-31
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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K133694 — SHERPA PAK TRANSPORTER2014-05-23
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Data sourced from openFDA. This site is unofficial and independent of the FDA.