510(k) · Cleared
ClearedNiox Vero
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circassia AB · MXA System, Test, Breath Nitric Oxide
Cleared on Nov 22, 2017 as substantially equivalent to K150233 (Aerocrine AB, 2015) after a 233-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.
- Decided
- Nov 22, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN030001 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 4 generations backK072816 Niox MinoAerocrine AB · 2008
- 3 generations backK101034 Niox Mino Model 09-1000Aerocrine AB · 2010
- 2 generations backK133898 Niox Vero Airway Inflammation MonitorAerocrine AB · 2014
- 1 generation backK150233 NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015
- This deviceK170983 Niox VeroCircassia AB · 2017
- Descendant · cites it directly · 0 of its ownK203695 NObreath®Bedfont Scientific, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203695NObreath®Bedfont Scientific, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| −4 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| −3 | K101034 | Niox Mino Model 09-1000 | Aerocrine AB | 2010 | — |
| −2 | K133898 | Niox Vero Airway Inflammation Monitor | Aerocrine AB | 2014 | — |
| −1 | K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015 | — |
| 0 (this device) | K170983 | Niox Vero | Circassia AB | 2017 | — |
| +1 | K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K150233 | NIOX VERO Airway Inflammation MonitorSummary page 4…MXA CFR Section: 21 CFR 862.3080 Predicate Device: NIOX VERO® Airway Inflammation Monitor 510(k) Clearance Number: K150233 Class II under 21 CFR 862.3080, Product Code MXA Circassia AB Circassia Technical Centre… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203695 | NObreath® | 2021 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K203695 (Bedfont Scientific, Ltd., 2021) has gone furthest, with 0 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. 2017, 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 VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society. Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, simple and safe method to measure the decrease in FeNO concentration…
Read the full statement (227 words)
NIOX VERO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in some airway inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO), can be measured by NIOX VERO according to guidelines for NO measurement established by the American Thoracic Society.
Measurement of FeNO by NIOX VERO 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 VERO is suitable for children, 7- 17 years, and adults 18 years and older.
NIOX VERO 10 second test mode is for age 7 and up
NIOX VERO 6 second test mode is for ages 7-10 only who cannot successfully complete a 10 second test.
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. The NIOX VERO is intended for prescription use and should only be used as directed in the NIOX VERO User Manual by trained healthcare professionals. NIOX VERO cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NIOX VERO should not be used in critical care, emergency care or in anesthesiology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170983: Niox Vero.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170983
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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