510(k) · Cleared
ClearedVivatmo pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bosch Healthcare Solutions GmbH · MXA System, Test, Breath Nitric Oxide
Cleared on Feb 22, 2024 after a 90-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Feb 22, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- MXA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK233775 Vivatmo proBosch Healthcare Solutions GmbH · 2024
- Descendant · cites it directly · 0 of its ownK243926 Vivatmo pro-SBosch Healthcare Solutions GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K243926Vivatmo pro-SBosch Healthcare Solutions GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K233775 | Vivatmo pro | Bosch Healthcare Solutions GmbH | 2024 | — |
| +1 | K243926 | Vivatmo pro-S | Bosch Healthcare Solutions GmbH | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K243926 | Vivatmo pro-S | 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?
- Of its descendants, K243926 (Bosch Healthcare Solutions GmbH, 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. 2024, 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?
Vivatmo 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 Vivatmo 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)
Vivatmo 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 Vivatmo 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.
Vivatmo pro is suitable for children, approximately 7-17 years, and adults 18 years and older.
Testing using the Vivatmo pro should only be done in a point-of-care healthcare setting under professional supervision.
Vivatmo 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/K233775 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233775: Vivatmo pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233775
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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