510(k) · Cleared
Recalled · Class II · 2021Fenom Pro Nitric Oxide Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirosure, Inc. · MXA System, Test, Breath Nitric Oxide
Cleared on Feb 13, 2019 as substantially equivalent to K072816 (Aerocrine AB, 2008) after a 124-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 2019
- Review
- 124 days
- Class
- Class II
- Product code
- MXA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN030001 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 1 generation backK072816 Niox MinoAerocrine AB · 2008
- This deviceK182874 Fenom Pro Nitric Oxide TestSpirosure, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK213611 Fenom ProCaire Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251674 Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019 | — |
| +1 | K213611 | Fenom Pro | Caire Diagnostics, Inc. | 2023 | — |
| +2 | K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 4…Classification: 21 CFR Part 862.3080 807.92 (a)(3): Identification of the legally marketed predicate devices NIOX MINO (Aerocrine AB, Morrisville, NC), K072816 807.92 (a)(4): Device Description Fenom Pro™ is a point-of-care breath analyzer that uses solid-state electrochemical technology… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213611 | Fenom Pro | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2021 | Class II | Z-1284-2021 | Process control | Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213611 (Caire Diagnostics, Inc., 2023) has gone furthest, with 1 descendant 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. 2019, 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?
Fenom Pro™ Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Fenom Pro™ is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological…
Read the full statement (138 words)
Fenom Pro™ Nitric Oxide Test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Fenom Pro™ 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 therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments. Fenom Pro™ is suitable for children, approximately 7-17 years, and adults 18 years and older.
Testing using the Fenom Pro™ should only be done in a point-of-care healthcare setting under professional supervision. Fenom Pro™ 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/K182874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182874: Fenom Pro Nitric Oxide Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182874
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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