# K031194: Spirosoft

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Jul 30, 2003 after 105 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout. The following caution label appears on page 2 of the SpiroSoft Instruction Manual: "Federal U.S. law restricts this device to sale by or on the order of a physician."

Source page: https://510kreport.com/device/K031194
Methodology: https://510kreport.com/methodology