FDA product code MRN: Apparatus, Nitric Oxide Delivery
MRN is the FDA product code for apparatus, nitric oxide delivery. It is a Class II device, regulated under 21 CFR 868.5165 and reviewed by the Anesthesiology panel. FDA has cleared 32 510(k) submissions under MRN, 9 in the last five years, from 17 different applicants. The average 510(k) review took 174 days (median 120); 158 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 18 recalls for MRN devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Nitric Oxide Delivery |
| Device class | Class II |
| Regulation | 21 CFR 868.5165 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MRN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 482 |
| 2020 | 3 | 78 |
| 2022 | 1 | 30 |
| 2023 | 4 | 478 |
| 2024 | 2 | 172 |
| 2025 | 2 | 144 |
Compare with all 510(k) review times · Search every MRN clearance
Top MRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ino Therapeutics | 6 | 2013-05-02 |
| Mallinckrodt Manufacturing, LLC | 4 | 2025-01-03 |
| Ino Therapeutics, LLC | 4 | 2010-03-10 |
| Linde Gas & Equipment, Inc. | 3 | 2024-05-23 |
| Ino Therapeutics/Ikaria | 2 | 2015-07-10 |
12 more applicants have MRN clearances. See the full list in Caduvo.
Most recent MRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242374 | Airgas Therapeutics, LLC | ULSPIRA TS Nitric Oxide Therapy System | 2025-01-17 | 161 |
| K242578 | Mallinckrodt Manufacturing, LLC | EVOLVE Nitric Oxide Delivery System | 2025-01-03 | 127 |
| K240410 | Malinckrodt Manufacturing, LLC | EVOLVE Nitric Oxide Delivery System | 2024-05-28 | 106 |
| K233251 | Linde Gas & Equipment, Inc. | NOxBOXi Nitric Oxide Delivery System | 2024-05-23 | 238 |
| K222930 | Mallinckrodt Manufacturing, LLC | Evolve Nitric Oxide Delivery System | 2023-12-06 | 436 |
Recalls for MRN devices
18 product recalls in 18 recall events; 8 initiated in the last five years and 7 still open. Most recent: 2026-09-14.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 2 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code MRN?
MRN is the FDA product code for apparatus, nitric oxide delivery. It is a Class II device, regulated under 21 CFR 868.5165 and reviewed by the Anesthesiology panel.
What device class is MRN?
Class II, regulation 21 CFR 868.5165. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRN?
Across 32 cleared submissions the average was 174 days from receipt to decision (median 120).
Which companies have the most MRN clearances?
Ino Therapeutics (6); Mallinckrodt Manufacturing, LLC (4); Ino Therapeutics, LLC (4); Linde Gas & Equipment, Inc. (3); Ino Therapeutics/Ikaria (2).
Have MRN devices been recalled?
Yes: 18 product recalls across 18 recall events; the most recent began 2026-09-14.
Next steps
- Run an FDA pathway report with predicate devices for product code MRN
- Run a recall and safety report across every MRN manufacturer
- Watch product code MRN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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