# K173937: SpiroSphere

- Pathway: 510(k) (Traditional)
- Applicant: Eresearchtechnology GmbH
- Decided: Feb 15, 2019 after 416 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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) Summary page 5.

## Indications for use
The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital.

Source page: https://510kreport.com/device/K173937
Methodology: https://510kreport.com/methodology