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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) 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. The listed applicant is Paragonix Technologies, Inc.. The 510(k) number is K254305.

When did BAROguard Donor Lung Preservation System receive FDA 510(k) clearance?

BAROguard Donor Lung Preservation System received FDA 510(k) clearance on 2026-01-30, under 510(k) number K254305.

Who is the listed applicant for BAROguard Donor Lung Preservation System?

The FDA 510(k) record lists Paragonix Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAROguard Donor Lung Preservation System?

The FDA product code for BAROguard Donor Lung Preservation System is KDN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02234128Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP FacilityCOMPLETEDNCT03112044Lung Transplant HCV, Pilot StudyACTIVE_NOT_RECRUITING

Other records listing Paragonix Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges LopezK243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life

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.

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