510(k) · Cleared
ClearedNObreath®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bedfont Scientific, Ltd. · MXA System, Test, Breath Nitric Oxide
Cleared on Dec 17, 2021 as substantially equivalent to K170983 (Circassia AB, 2017) after a 364-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Dec 17, 2021
- Review
- 364 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN030001 (2003). No later device cites it as a predicate yet.
- Root · 6 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 5 generations backK072816 Niox MinoAerocrine AB · 2008
- 4 generations backK101034 Niox Mino Model 09-1000Aerocrine AB · 2010
- 3 generations backK133898 Niox Vero Airway Inflammation MonitorAerocrine AB · 2014
- 2 generations backK150233 NIOX VERO Airway Inflammation MonitorAerocrine AB · 2015
- 1 generation backK170983 Niox VeroCircassia AB · 2017
- This deviceK203695 NObreath®Bedfont Scientific, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| −5 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| −4 | K101034 | Niox Mino Model 09-1000 | Aerocrine AB | 2010 | — |
| −3 | K133898 | Niox Vero Airway Inflammation Monitor | Aerocrine AB | 2014 | — |
| −2 | K150233 | NIOX VERO Airway Inflammation Monitor | Aerocrine AB | 2015 | — |
| −1 | K170983 | Niox Vero | Circassia AB | 2017 | — |
| 0 (this device) | K203695 | NObreath® | Bedfont Scientific, Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K170983 | Niox VeroSummary page 4…h nitric oxide Product Code: MXA Regulatory Class: II Predicate Device: Circassia AB NIOX VERO (K170983) Device Description: NObreath® is a portable system for the non‐invasive, quantitative measurement of the fraction of exhaled ni… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
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. 2021, 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?
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a 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…
Read the full statement (205 words)
The NObreath® is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath. The production of nitric oxide is often found to be increased in inflammatory conditions such as asthma. Measurement of FeNO by NObreath® is a 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.
The fractional NO concentration in expired breath (FeNO), can be measured by NObreath® according to guidelines for NO measurement established by the American Thoracic Society.
NObreath® is intended for children, 7- 17 years, and adults 18 years and older. NObreath® 12 second test mode is for age 7 and up
NObreath® 10 second test mode is for ages 7-10 only who cannot successfully complete a 12 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 NObreath® cannot be used with infants or by children under the age of 7 as measurement requires patient cooperation.
NObreath® should not be used in critical care, emergency care or in anesthesiology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203695: NObreath®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203695
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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