BAROguard Donor Lung Preservation System
K-Number: K254305 · 2026-01-30
ApplicantParagonix Technologies, Inc.
Decision Date2026-01-30
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BAROguard Donor Lung Preservation System is a medical device manufactured by Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-30 under approval number K254305. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BAROguard Donor Lung Preservation System?
BAROguard Donor Lung Preservation System is a medical device that received FDA 510(k) clearance on 2026-01-30. It is manufactured by Paragonix Technologies, Inc.. The 510(k) number is K254305.
When was BAROguard Donor Lung Preservation System approved by the FDA?
BAROguard Donor Lung Preservation System received FDA 510(k) clearance on 2026-01-30, under approval number K254305.
What company makes BAROguard Donor Lung Preservation System?
BAROguard Donor Lung Preservation System is manufactured by Paragonix Technologies, Inc..
What is the FDA product code for BAROguard Donor Lung Preservation System?
The FDA product code for BAROguard Donor Lung Preservation System is KDN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.