MRN
- Product code
- MRN
- Device name
- Apparatus, Nitric Oxide Delivery
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5165
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 33 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242374 | 2025-01-17 | Airgas Therapeutics, LLC | ULSPIRA TS Nitric Oxide Therapy System | |
| K242578 | 2025-01-03 | Mallinckrodt Manufacturing, LLC | EVOLVE Nitric Oxide Delivery System | |
| K240410 | 2024-05-28 | Malinckrodt Manufacturing, LLC | EVOLVE Nitric Oxide Delivery System | |
| K233251 | 2024-05-23 | Linde Gas & Equipment, Inc. | NOxBOXi Nitric Oxide Delivery System | |
| K222930 | 2023-12-06 | Mallinckrodt Manufacturing, LLC | Evolve Nitric Oxide Delivery System | FDA |
Official FDA classification page: MRN
Classification and pathway per current FDA publications. Data from openFDA (CC0).