# K233775: Vivatmo pro

- Pathway: 510(k) (Traditional)
- Applicant: Bosch Healthcare Solutions GmbH
- Decided: Feb 22, 2024 after 90 days
- Product code: MXA (System, Test, Breath Nitric Oxide)
- Device class: 2
- Regulation: 21 CFR 862.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K243926: Vivatmo pro-S (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K233775
Methodology: https://510kreport.com/methodology