De Novo · Granted
GrantedNiox Article NO: 02-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aerocrine AB · MXA System, Test, Breath Nitric Oxide
Granted on Apr 30, 2003 as a new device type through De Novo after a 43-day review. 10 later devices descend from it.
- Decided
- Apr 30, 2003
- Review
- 43 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
10 later devices descend from it, 1 citing it directly.
- This deviceDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- Descendant · cites it directly · 9 of its ownK072816 Niox MinoAerocrine AB · 2008
- Descendant · 2 generations on · 5 of its ownK101034 Niox Mino Model 09-1000Aerocrine AB · 2010
- Descendant · 3 generations on · 3 of its ownK133898 Niox Vero Airway Inflammation MonitorAerocrine AB · 2014
- Descendant · 2 generations on · 2 of its ownK182874 Fenom Pro Nitric Oxide TestSpirosure, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 2 of its ownK150233 NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072816Niox MinoAerocrine AB · 2008 · cites it directly9descendants
- K101034Niox Mino Model 09-1000Aerocrine AB · 2010 · 2 generations on5descendants
- K133898Niox Vero Airway Inflammation MonitorAerocrine AB · 2014 · 3 generations on3descendants
- K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. · 2019 · 2 generations on2descendants
- K150233NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| +1 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| +2 | K101034 | Niox Mino Model 09-1000 | Aerocrine AB | 2010 | — |
| +3 | K133898 | Niox Vero Airway Inflammation Monitor | Aerocrine AB | 2014 | — |
| +2 | K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019 | 1 |
| +4 | K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MXA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MXA device
- #1 K251674 Fenom Flo™ FeNO Monitoring Systemscore 11.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072816 | Niox Mino | 2008 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072816 (Aerocrine AB, 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MXA devicesMXA System, Test, Breath Nitric Oxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXA
Too few MXA 510(k)s in any year since 2007 to give a median.
Recalls per year · MXA
No recall names MXA since 2007.
Adverse event reports per year · MXA
No MAUDE report names MXA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN030001 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN030001: Niox Article NO: 02-1000.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN030001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026