The NOxBOXi Nitric Oxide Delivery System
FDA 510(k) K201339 · Praxair, Inc.
510(k) numberK201339
Submission
- Device name
- The NOxBOXi Nitric Oxide Delivery System
- Applicant
- Praxair, Inc.
Danbury, CT, US - Received
- May 20, 2020
- Decision date
- June 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRN – Apparatus, Nitric Oxide Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5165
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K242374 | ULSPIRA TS Nitric Oxide Therapy SystemMRN · Special | Airgas Therapeutics, LLC | 01/17/2025SE |
| K242578 | EVOLVE Nitric Oxide Delivery SystemMRN · Special | Mallinckrodt Manufacturing, LLC | 01/03/2025SE |
| K240410 | EVOLVE Nitric Oxide Delivery SystemMRN · Special | Malinckrodt Manufacturing, LLC | 05/28/2024SE |
| K233251 | NOxBOXi Nitric Oxide Delivery SystemMRN · Traditional | Linde Gas & Equipment, Inc. | 05/23/2024SE |
| K222930 | Evolve Nitric Oxide Delivery SystemMRN · Traditional | Mallinckrodt Manufacturing, LLC | 12/06/2023SE |
| K231823 | NOxBOXi Nitric Oxide Delivery SystemMRN · Special | Linde Gas & Equipment, Inc. | 08/11/2023SE |
| K212409 | Ulspira TS Nitric Oxide Therapy SystemMRN · Traditional | Airgas Therapeutics | 06/30/2023SE |
| K211153 | Inomax DSIRMRN · Traditional | Mallinckrodt Manufacturing, LLC | 04/20/2023SE |
| K220898 | NOxBOXi Nitric Oxide Delivery SystemMRN · Special | Linde Gas & Equipment, Inc. | 04/27/2022SE |
| K200389 | INOmax DSIR PlusMRN · Special | Mallinckrodt Manufacturing, LLC | 06/17/2020SE |
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| K051192 | Praxair Medical Air MixerBZR · Traditional | 09/06/2005SE |
Questions and answers
When was The NOxBOXi Nitric Oxide Delivery System cleared by the FDA?
The NOxBOXi Nitric Oxide Delivery System (K201339) received a 510(k) decision of Substantially Equivalent on June 19, 2020, 30 days after the submission was received.
What is the product code of K201339?
The FDA product code is MRN – Apparatus, Nitric Oxide Delivery, a Class II (moderate risk) device regulated under 21 CFR 868.5165.