Madison, WI, US · 4 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | Class II | Anesthesiology | 4 | 2025-01-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-08-08 | Class I | Ongoing | Z-2450-2023 | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators. | — | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-03 | K242578 | EVOLVE Nitric Oxide Delivery System | MRN | Class II | Anesthesiology |
| 2023-12-06 | K222930 | Evolve Nitric Oxide Delivery System | MRN | Class II | Anesthesiology |
| 2023-04-20 | K211153 | Inomax DSIR | MRN | Class II | Anesthesiology |
| 2020-06-17 | K200389 | INOmax DSIR Plus | MRN | Class II | Anesthesiology |