510(k) · Cleared
ClearedFenom Flo™ FeNO Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mgc Diagnostics Corporation · MXA System, Test, Breath Nitric Oxide
Cleared on Nov 26, 2025 as substantially equivalent to K213611 (Caire Diagnostics, Inc., 2023) after a 180-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Nov 26, 2025
- Review
- 180 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN030001 (2003). No later device cites it as a predicate yet.
- Root · 4 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 3 generations backK072816 Niox MinoAerocrine AB · 2008
- 2 generations backK182874 Fenom Pro Nitric Oxide TestSpirosure, Inc. · 2019 · Recalled
- 1 generation backK213611 Fenom ProCaire Diagnostics, Inc. · 2023
- This deviceK251674 Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| −3 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| −2 | K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019 | 1 |
| −1 | K213611 | Fenom Pro | Caire Diagnostics, Inc. | 2023 | — |
| 0 (this device) | K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | 2025 | — |
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 K243926 Vivatmo pro-Sscore 10.0 · 1 generation · 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 |
|---|---|---|---|
| * | K213611 | Fenom ProSummary page 5…Flo™ FeNO Monitoring System Model Number: 8000 Common Name: FeNO Monitoring System Classification: Breath Nitric Oxide Test System, 21 CFR 862.3080, MXA Predicate Device:K213611, Fenom Pro™ Intended Use/Indications for Use: Fenom Flo™ FeNO Monitoring System is a portable, non-invasive device to measure fra… | 2023 |
| † | K042758 | Polytech Pulmonary Function Filter | 2005 |
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 22 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2025, 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 Flo™ FeNO Monitoring System 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 decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society. Measurement of FeNO by Fenom Flo is a non-invasive quantitative…
Read the full statement (149 words)
Fenom Flo™ FeNO Monitoring System 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 decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society.
Measurement of FeNO by Fenom Flo is a non-invasive quantitative 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 Flo is suitable for adults and children ages seven years and older.
Fenom Flo should be used in a point-of-care healthcare setting under professional supervision. Fenom Flo should not be used in critical care, emergency care, or anesthesiology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251674: Fenom Flo™ FeNO Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251674
Report an extraction error
Are you the manufacturer?
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