# K231561: Pulmonary Function Tester, Model: A9

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Homesun Medical Technology Co., Ltd.
- Decided: Feb 21, 2024 after 266 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 K071753 (2007). 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)
- K071753: Masterscreen Pneumo & Masterscope, Viasys Healthcare GmbH (2007) Summary page 5.

## Indications for use
The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements. Measurements shall be performed under the direction of a physician in the clinic, doctors’ office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.

Source page: https://510kreport.com/device/K231561
Methodology: https://510kreport.com/methodology