AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
FDA 510(k) clearance K193481 · decided 2020-03-10
Clearance details
- K-number
- K193481
- Device name
- AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
- Applicant
- International Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2019-12-17
- Decision date
- 2020-03-10
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- MRN
- Device class
- 2
- Regulation number
- 868.5165
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |
| EVOLVE Nitric Oxide Delivery System (K242578) | Mallinckrodt Manufacturing, LLC | 2025-01-03 |
| EVOLVE Nitric Oxide Delivery System (K240410) | Malinckrodt Manufacturing, LLC | 2024-05-28 |
| NOxBOXi Nitric Oxide Delivery System (K233251) | Linde Gas & Equipment, Inc. | 2024-05-23 |
| Evolve Nitric Oxide Delivery System (K222930) | Mallinckrodt Manufacturing, LLC | 2023-12-06 |
| NOxBOXi Nitric Oxide Delivery System (K231823) | Linde Gas & Equipment, Inc. | 2023-08-11 |
| Ulspira TS Nitric Oxide Therapy System (K212409) | Airgas Therapeutics | 2023-06-30 |
| Inomax DSIR (K211153) | Mallinckrodt Manufacturing, LLC | 2023-04-20 |
| NOxBOXi Nitric Oxide Delivery System (K220898) | Linde Gas & Equipment, Inc. | 2022-04-27 |
| The NOxBOXi Nitric Oxide Delivery System (K201339) | Praxair, Inc. | 2020-06-19 |
| INOmax DSIR Plus (K200389) | Mallinckrodt Manufacturing, LLC | 2020-06-17 |
| NOxBOXi Nitric Oxide Delivery System (K171696) | Praxair Distribution, Inc. | 2018-10-02 |
Recalls involving this device
No recalls on record reference this clearance.