# K092324: Spiropro

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Sep 3, 2009 after 30 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000648 (2000). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031515: Spiropro SPO2, Viasys Healthcare GmbH (2003) Summary page 2.
- K090486: Asthma Monitor Model, AM1, Cardinal Health Germany 234 GmbH (2009) Summary page 2.

## Most influential descendants
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), 6 descendants of its own
- K200550: Vitalograph Model 2120 In2itive eDiary (2020), 2 descendants of its own
- K212938: Vitalograph Model 6000 Alpha (2022), 1 descendant of its own
- K142812: Vitalograph Model 6800 Pneumotrac (2015), 1 descendant of its own
- K251777: MESI mTABLET SPIRO (2026), 0 descendants of its own

## Indications for use
The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.

Source page: https://510kreport.com/device/K092324
Methodology: https://510kreport.com/methodology