# K031515: Spiropro SPO2

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: Nov 14, 2003 after 184 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: 1 generation back to K000648 (2000). 2 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000648: Spiro Pro, Erich Jaeger GmbH (2000)
- K001995: Spiroxcard Diagnostic Spirometer and Pulse Oximeter, Qrs Diagnostic, LLC (2000)

## Most influential descendants
- K092324: Spiropro (2009), 9 descendants of its own
- 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

## Indications for use
The SpiroPro Sp02 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 Sp02 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/K031515
Methodology: https://510kreport.com/methodology