Data / Medical devices / Apparatus, Nitric Oxide Delivery
Apparatus, Nitric Oxide Delivery (MRN): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Apparatus, Nitric Oxide Delivery (product code MRN, Class 2, 21 CFR 868.5165). 4 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on January 17, 2025, and lists 18 recall events (5 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MRN
- Device class
- 2
- Regulation
- 868.5165
- Medical specialty
- Anesthesiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| United Kingdom | 2 |
| China | 1 |
| France | 1 |
Makers of Apparatus, Nitric Oxide Delivery
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Manufacturer, Remanufacturer | 17 | December 6, 2023 | 0 | 5 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 3 | March 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Manufacturer | 2 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Noxbox Limited | Sittingbourne Kent, United Kingdom | Manufacturer | 1 | May 23, 2024 | 0 | 6 | 3 | api.fda.gov |
| AOK Tooling Limited | Shen Zhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C2C Development, LLC | Melbourne, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inosystems | ANTONY Hauts-de-Seine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Technologies Ltd. | ASHFORD Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vero Biotech Inc. | Livingston, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.