510(k) · Cleared
ClearedFenom Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caire Diagnostics, Inc. · MXA System, Test, Breath Nitric Oxide
Cleared on Jun 7, 2023 as substantially equivalent to K182874 (Spirosure, Inc., 2019) after a 569-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Jun 7, 2023
- Review
- 569 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN030001 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN030001 Niox Article NO: 02-1000Aerocrine AB · 2003
- 2 generations backK072816 Niox MinoAerocrine AB · 2008
- 1 generation backK182874 Fenom Pro Nitric Oxide TestSpirosure, Inc. · 2019 · Recalled
- This deviceK213611 Fenom ProCaire Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251674 Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN030001 | Niox Article NO: 02-1000 | Aerocrine AB | 2003 | — |
| −2 | K072816 | Niox Mino | Aerocrine AB | 2008 | — |
| −1 | K182874 | Fenom Pro Nitric Oxide Test | Spirosure, Inc. | 2019 | 1 |
| 0 (this device) | K213611 | Fenom Pro | Caire Diagnostics, Inc. | 2023 | — |
| +1 | K251674 | Fenom Flo™ FeNO Monitoring System | Mgc Diagnostics Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K182874 | Fenom Pro Nitric Oxide TestSummary page 4…Trade name: Fenom Pro™ Nitric Oxide Test Predicate Manufacturer: Spirosure Inc. Predicate 510(k) Clearance: K182874 510(k) Summary Page 1 of 4… | 2019 |
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 |
|---|---|---|---|
| K251674 | Fenom Flo™ FeNO Monitoring System | 2025 | 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 20 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K251674 (Mgc Diagnostics Corporation, 2025) 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. 2023, 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 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 Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society. Measurement of FENO by Fenom Pro is a non-invasive quantitative method to measure the decrease…
Read the full statement (145 words)
Fenom Pro 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 Pro measures fractional exhaled nitric oxide according to guidelines established by the American Thoracic Society.
Measurement of FENO by Fenom Pro 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 Pro is suitable for adults and children 6 years and older.
Fenom Pro should be used 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/K213611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213611: Fenom Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213611
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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