510(k) · Cleared
ClearedNiox Mino Model 09-1000
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
Cleared on Sep 2, 2010 as substantially equivalent to K072816 (Aerocrine AB, 2008) after a 141-day review. Its family tree reaches back 2 generations to 2003. 5 later devices descend from it.
- Decided
- Sep 2, 2010
- Review
- 141 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN030001 (2003). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 1 generation backK072816 Niox MinoAerocrine AB · 2008
- This deviceK101034 Niox Mino Model 09-1000Aerocrine AB · 2010
- Descendant · cites it directly · 3 of its ownK133898 Niox Vero Airway Inflammation MonitorAerocrine AB · 2014
- Descendant · 2 generations on · 2 of its ownK150233 NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015
- Descendant · 3 generations on · 1 of its ownK170983 Niox VeroCircassia AB · 2017
- Descendant · 4 generations on · 0 of its ownK203695 NObreath®Bedfont Scientific, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK123683 Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB · 2012
Most influential descendants
Showing 5 of 5 · See all- K133898Niox Vero Airway Inflammation MonitorAerocrine AB · 2014 · cites it directly3descendants
- K150233NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015 · 2 generations on2descendants
- K170983Niox VeroCircassia AB · 2017 · 3 generations on1descendant
- K203695NObreath®Bedfont Scientific, Ltd. · 2021 · 4 generations on0descendants
- K123683Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| −1 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| 0 (this device) | K101034 | Niox Mino Model 09-1000 | Aerocrine AB | 2010 | — |
| +1 | K133898 | Niox Vero Airway Inflammation Monitor | Aerocrine AB | 2014 | — |
| +2 | K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015 | — |
| +3 | K170983 | Niox Vero | Circassia AB | 2017 | — |
| +4 | K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021 | — |
| +1 | K123683 | Niox Panel for Use with the Niox Mino Airway Inflammation Monitor | Aerocrine AB | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072816 | Niox MinoSummary page 2…: Trade name NIOX MINO® Common/Generic Device Name Airway inflammation monitor Initial 5 10(k) number K0728 16 5 10(k) number, device modification: KI101034 Classification Name Breath Nitric Oxide Test System De… | 2008 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133898 (Aerocrine AB, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K072816.
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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FENO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FENO by NIOX MINO is a quantitative, non-invasive, simple and safe method to measure the decrease in FENO concentration in asthma…
Read the full statement (205 words)
NIOX MINO measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some inflammatory processes such as asthma. The fractional NO concentration in expired breath (FENO), can be measured by NIOX MINO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FENO by NIOX MINO is a quantitative, non-invasive, simple and safe method to measure the decrease in FENO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy, as an indication of the therapeutic effect in patients with elevated FENO levels. NIOX MINO is suitable for children, approximately 7 - 17 years, and adults 18 years and older.
FENO measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. NIOX MINO should only be used as directed in the NIOX MINO User Manual and the NIOX MINO Quality Control Test User Manual, by trained physicians, nurses, respiratory therapists and laboratory technicians. NIOX MINO cannot be used with infants or by children approximately under the age of 7, as measurement requires patient cooperation. NIOX MINO should not be used in critical care, emergency care or in anaesthesiology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101034: Niox Mino Model 09-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101034
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026