MRN · Apparatus, Nitric Oxide Delivery
Anesthesiology · 21 CFR 868.5165 · Class 2
Overview
| Product Code | MRN |
|---|---|
| Device Name | Apparatus, Nitric Oxide Delivery |
| Regulation | 21 CFR 868.5165 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
Special Controls
The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242374 | ULSPIRA TS Nitric Oxide Therapy System | Airgas Therapeutics, LLC | Jan 17, 2025 | SESE |
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | Jan 3, 2025 | SESE |
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | May 28, 2024 | SESE |
| K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | May 23, 2024 | SESE |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | Dec 6, 2023 | SESE |
| K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | Aug 11, 2023 | SESE |
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | Jun 30, 2023 | SESE |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | Apr 20, 2023 | SESE |
| K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | Apr 27, 2022 | SESE |
| K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | Jun 19, 2020 | SESE |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | Jun 17, 2020 | SESE |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | Mar 10, 2020 | SESE |
| K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | Oct 2, 2018 | SESE |
| K143213 | INOmax DSIR Plus MRI | Ino Therapeutics/Ikaria | Jul 10, 2015 | SESE |
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics/Ikaria | Nov 29, 2013 | SESE |
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | May 2, 2013 | SESE |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics | Sep 24, 2012 | SESE |
| K120216 | GENOSYL MV-1000 | Geno, LLC | May 16, 2012 | SESE |
| K113272 | INOMAX DS(DELIVERY SYSTEMS | Ino Therapeutics, LLC/Dba Ikaria | Feb 29, 2012 | SESE |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | Jun 24, 2011 | SESE |
Top Applicants
- Ino Therapeutics — 6 clearances
- Ino Therapeutics, LLC — 4 clearances
- Mallinckrodt Manufacturing, LLC — 4 clearances
- Linde Gas & Equipment, Inc. — 3 clearances
- Ino Therapeutics, LLC/Dba Ikaria — 2 clearances
