# K201562: Spirotrac

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph Ireland, Ltd.
- Decided: Oct 14, 2020 after 126 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943404 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141546: Vitalograph Model 7000 Spirotrac, Vitalograph (Ireland), Ltd. (2014) Summary page 4.

## Indications for use
The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

Source page: https://510kreport.com/device/K201562
Methodology: https://510kreport.com/methodology