FDA product code MXA: System, Test, Breath Nitric Oxide
MXA is the FDA product code for system, test, breath nitric oxide. It is a Class II device, regulated under 21 CFR 862.3080 and reviewed by the Clinical Chemistry panel. FDA has cleared 14 510(k) submissions under MXA, 4 in the last five years, from 8 different applicants. The average 510(k) review took 190 days (median 147); 156 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for MXA devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Breath Nitric Oxide |
| Device class | Class II |
| Regulation | 21 CFR 862.3080 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
510(k) clearances per year for MXA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 233 |
| 2019 | 1 | 124 |
| 2021 | 1 | 364 |
| 2023 | 1 | 569 |
| 2024 | 1 | 90 |
| 2025 | 2 | 222 |
Compare with all 510(k) review times · Search every MXA clearance
Top MXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aerocrine AB | 5 | 2015-02-26 |
| Bosch Healthcare Solutions GmbH | 2 | 2025-09-11 |
| Apieron, Inc. | 2 | 2009-01-27 |
| Mgc Diagnostics Corporation | 1 | 2025-11-26 |
| Caire Diagnostics, Inc. | 1 | 2023-06-07 |
3 more applicants have MXA clearances. See the full list in Caduvo.
Most recent MXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251674 | Mgc Diagnostics Corporation | Fenom Flo FeNO Monitoring System | 2025-11-26 | 180 |
| K243926 | Bosch Healthcare Solutions GmbH | Vivatmo pro-S | 2025-09-11 | 265 |
| K233775 | Bosch Healthcare Solutions GmbH | Vivatmo pro | 2024-02-22 | 90 |
| K213611 | Caire Diagnostics, Inc. | Fenom Pro | 2023-06-07 | 569 |
| K203695 | Bedfont Scientific, Ltd. | NObreath® | 2021-12-17 | 364 |
Recalls for MXA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-26.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code MXA?
MXA is the FDA product code for system, test, breath nitric oxide. It is a Class II device, regulated under 21 CFR 862.3080 and reviewed by the Clinical Chemistry panel.
What device class is MXA?
Class II, regulation 21 CFR 862.3080. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXA?
Across 14 cleared submissions the average was 190 days from receipt to decision (median 147).
Which companies have the most MXA clearances?
Aerocrine AB (5); Bosch Healthcare Solutions GmbH (2); Apieron, Inc. (2); Mgc Diagnostics Corporation (1); Caire Diagnostics, Inc. (1).
Have MXA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-02-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MXA
- Run a recall and safety report across every MXA manufacturer
- Watch product code MXA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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