FDA.reportPublic FDA data

510(k) K254305

Device
BAROguard Donor Lung Preservation System
Applicant
Paragonix Technologies, Inc.
510(k) number
K254305
Product code
KDN
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-30
Date received
2025-12-31
Regulation
876.5880
Classification name
System, Perfusion, Kidney
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
Julia Bryant
Address
950 Winter St. North Waltham MA US 02451 02451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KDN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO Life2025-06-17
K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.2025-05-01
K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez2025-04-25
K243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life2025-03-31
K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life2025-03-26
K240650LungProtectTraferox Technologies, Inc.2024-11-26
K234060KIDNEYvault Portable Renal Perfusion SystemParagonix Technologies2024-10-23
K230193Servator P Plus SALF SolutionS.A.L.F. Spa2023-09-21
K223874BAROguardParagonix Technologies2023-08-15
K211333KIDNEY ASSIST-transportXvivo Perfusion AB2022-01-20
K211224RM4 Control UnitInstitut Georges Lopez2021-10-15
K202652Servator P SALF Solution with THAMS.A.L.F. Spa2021-08-19
K203262Cannula for Organ PerfusionBridge TO Life, Ltd.2021-07-01
K201048SherpaPak Pediatric Liver Transport SystemParagonix Technologies2020-07-02
K192869SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemPragonix Technologies2020-01-16