MRN — Apparatus, Nitric Oxide Delivery Class II
FDA product code MRN covers "Apparatus, Nitric Oxide Delivery", a Class II medical device regulated under 21 CFR 868.5165. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242374 | airgas therapeutics | ULSPIRA TS Nitric Oxide Therapy System | January 17, 2025 |
| K242578 | mallinckrodt manufacturing | EVOLVE Nitric Oxide Delivery System | January 3, 2025 |
| K240410 | malinckrodt manufacturing | EVOLVE Nitric Oxide Delivery System | May 28, 2024 |
| K233251 | linde gas and equipment | NOxBOXi Nitric Oxide Delivery System | May 23, 2024 |
| K222930 | mallinckrodt manufacturing | Evolve Nitric Oxide Delivery System | December 6, 2023 |
| K231823 | linde gas and equipment | NOxBOXi Nitric Oxide Delivery System | August 11, 2023 |
| K212409 | airgas therapeutics | Ulspira TS Nitric Oxide Therapy System | June 30, 2023 |
| K211153 | mallinckrodt manufacturing | Inomax DSIR | April 20, 2023 |
| K220898 | linde gas and equipment | NOxBOXi Nitric Oxide Delivery System | April 27, 2022 |
| K201339 | praxair | The NOxBOXi Nitric Oxide Delivery System | June 19, 2020 |
| K200389 | mallinckrodt manufacturing | INOmax DSIR Plus | June 17, 2020 |
| K193481 | international biomedical | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | March 10, 2020 |
| K171696 | praxair distribution | NOxBOXi Nitric Oxide Delivery System | October 2, 2018 |
| K143213 | ino therapeutics/ikaria | INOmax DSIR Plus MRI | July 10, 2015 |
| K131686 | ino therapeutics/ikaria | INOMAX DSIR (DELIVERY SYSTEM) | November 29, 2013 |
| K130605 | ino therapeutics | INOMAX DSIR (DELIVERY SYSTEM) | May 2, 2013 |
| K121021 | ino therapeutics | INOMAX DS (DELIVERY SYSTEM) | September 24, 2012 |
| K120216 | geno | GENOSYL MV-1000 | May 16, 2012 |
| K113272 | ino therapeutics, llc/dba ikaria | INOMAX DS(DELIVERY SYSTEMS | February 29, 2012 |
| K110344 | ino therapeutics | INOMAX DSIR (DELIVERY SYSTEM) | June 24, 2011 |