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MRN — Apparatus, Nitric Oxide Delivery Class II

FDA Device Classification

Classification Details

Product Code
MRN
Device Class
Class II
Regulation Number
868.5165
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242374airgas therapeuticsULSPIRA TS™ Nitric Oxide Therapy SystemJanuary 17, 2025
K242578mallinckrodt manufacturingEVOLVE Nitric Oxide Delivery SystemJanuary 3, 2025
K240410malinckrodt manufacturingEVOLVE Nitric Oxide Delivery SystemMay 28, 2024
K233251linde gas and equipmentNOxBOXi Nitric Oxide Delivery SystemMay 23, 2024
K222930mallinckrodt manufacturingEvolve Nitric Oxide Delivery SystemDecember 6, 2023
K231823linde gas and equipmentNOxBOXi Nitric Oxide Delivery SystemAugust 11, 2023
K212409airgas therapeuticsUlspira TS Nitric Oxide Therapy SystemJune 30, 2023
K211153mallinckrodt manufacturingInomax DSIRApril 20, 2023
K220898linde gas and equipmentNOxBOXi Nitric Oxide Delivery SystemApril 27, 2022
K201339praxairThe NOxBOXi Nitric Oxide Delivery SystemJune 19, 2020
K200389mallinckrodt manufacturingINOmax DSIR PlusJune 17, 2020
K193481international biomedicalAeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemMarch 10, 2020
K171696praxair distributionNOxBOXi Nitric Oxide Delivery SystemOctober 2, 2018
K143213ino therapeutics/ikariaINOmax DSIR Plus MRIJuly 10, 2015
K131686ino therapeutics/ikariaINOMAX DSIR (DELIVERY SYSTEM)November 29, 2013
K130605ino therapeuticsINOMAX DSIR (DELIVERY SYSTEM)May 2, 2013
K121021ino therapeuticsINOMAX DS (DELIVERY SYSTEM)September 24, 2012
K120216genoGENOSYL MV-1000May 16, 2012
K113272ino therapeutics, llc/dba ikariaINOMAX DS(DELIVERY SYSTEMSFebruary 29, 2012
K110344ino therapeuticsINOMAX DSIR (DELIVERY SYSTEM)June 24, 2011