Product code MRN
- Device name
- Apparatus, Nitric Oxide Delivery
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5165
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | 2025-01-17 |
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2025-01-03 |
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | 2024-05-28 |
| K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2024-05-23 |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2023-12-06 |
| K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2023-08-11 |
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023-06-30 |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023-04-20 |
| K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2022-04-27 |
| K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | 2020-06-19 |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020-06-17 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020-03-10 |
| K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | 2018-10-02 |
| K143213 | INOmax DSIR Plus MRI | Ino Therapeutics/Ikaria | 2015-07-10 |
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics/Ikaria | 2013-11-29 |
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2013-05-02 |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics | 2012-09-24 |
| K120216 | GENOSYL MV-1000 | Geno, LLC | 2012-05-16 |
| K113272 | INOMAX DS(DELIVERY SYSTEMS | Ino Therapeutics, LLC/Dba Ikaria | 2012-02-29 |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2011-06-24 |
| K110635 | INOMAX DS(IR) (DELIVERY SYSTEM) | Ino Therapeutics, LLC/Dba Ikaria | 2011-06-23 |
| K093922 | INOMAX DS | Ino Therapeutics | 2010-04-15 |
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2010-03-10 |
| K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | International Biomedical, Ltd. | 2009-12-16 |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics, LLC | 2008-08-28 |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2008-08-06 |
| K071516 | INOMAX DS | Ino Therapeutics, LLC | 2007-10-03 |
| K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2007-04-27 |
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2006-12-14 |
| K033779 | VIANOX DELIVERY SYSTEM, MODEL II | Pulmonox Medical, Inc. | 2004-01-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810055280152 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 10810055280145 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 10810055280107 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280094 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280100 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280148 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280155 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280063 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280070 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055280087 | INOmax | Mallinckrodt Manufacturing LLC | 2024-03-29 |
| 00810055285082 | INOmax | Mallinckrodt Manufacturing LLC | 2023-02-01 |
| 00810055285099 | INOmax | Mallinckrodt Manufacturing LLC | 2023-02-01 |
| 00810055285051 | INOmax | Mallinckrodt Manufacturing LLC | 2023-02-01 |
| 05060541640030 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640191 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640184 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640085 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640078 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640061 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640054 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640047 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 15060541640112 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640023 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 05060541640016 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 15060541640167 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 15060541640143 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 15060541640136 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 15060541640129 | NOxBOXi | NOXBOX LTD | 2018-11-05 |
| 00867538000113 | INOmax DSIR Plus MRI | Mallinckrodt Manufacturing LLC | 2016-09-11 |
| 00867538000106 | INOmax DSIR Plus | Mallinckrodt Manufacturing LLC | 2016-09-11 |