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Panels › Anesthesiology › Product code MRN · Class 2

Apparatus, Nitric Oxide Delivery

Regulation 868.5165

0510(k)s in 12 months (33 all time)
2recalls in 12 months (18 all time)
15recalls that name a 510(k)
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Top companies in MRN

Company510(k)sRecalls
Ino Therapeutics102
Ino Therapeutics, LLC/Dba Ikaria25
NOXBOX LTD06
Mallinckrodt Manufacturing, LLC40
Linde Gas & Equipment, Inc.30
Vero Biotech, LLC03
Airgas Therapeutics20
Ino Therapeutics/Ikaria20
International Biomedical20
Pulmonox Medical Corp.20
DateFirm and productCodeLinked 510(k)
Sep 25, 2026NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Open, Classified		 MRNK171696
K201339 +3
Sep 15, 2026NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System.
Open, Classified		 MRNK171696
K201339 +3
Oct 6, 2025NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Open, Classified		 MRNK171696
K201339 +3
Oct 6, 2025NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Open, Classified		 MRNK171696
K201339 +3
Sep 9, 2025NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System
Open, Classified		 MRNK171696
Dec 15, 2023Vero Biotech, LLC
VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Open, Classified		 MRNNone listed
Jun 9, 2023NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Terminated		 MRNK171696
Sep 13, 2022Mallinckrodt, LLC.
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of n
Open, Classified		 MRNK061901
Sep 9, 2021Vero Biotech, LLC
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Completed		 MRNNone listed
Jun 23, 2021Vero Biotech, LLC
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Terminated		 MRNNone listed
Jul 9, 2018INO therapeutics LLC/dba ikaria
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the deliver
Terminated		 MRNK131686
Nov 21, 2016INO Therapeutics (dba Ikaria)
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of
Terminated		 MRNK131686
Feb 27, 2015INO Therapeutics (dba Ikaria)
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Terminated		 MRNK093922
Dec 12, 2014INO Therapeutics (dba Ikaria)
INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO
Terminated		 MRNK131686
May 2, 2014INO Therapeutics (dba Ikaria)
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous mo
Terminated		 MRNK131686
Jan 11, 2012Ino Therapeutics
INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in
Terminated		 MRNK061901
Aug 13, 2010Ikaria Holdings
Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 USA. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspi
Terminated		 MRNK061901
Aug 25, 2006INO Therapeutics, Inc.
INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
Terminated		 MRNK000186

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