NOxBOXi Nitric Oxide Delivery System
FDA 510(k) clearance K220898 · decided 2022-04-27
Clearance details
- K-number
- K220898
- Device name
- NOxBOXi Nitric Oxide Delivery System
- Applicant
- Linde Gas & Equipment, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-28
- Decision date
- 2022-04-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MRN
- Device class
- 2
- Regulation number
- 868.5165
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tonawanda, NY, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I recall (Z-0028-2026) | NOXBOX LTD | 2025-10-06 |
| NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I recall (Z-0029-2026) | NOXBOX LTD | 2025-10-06 |