# K141546: Vitalograph Model 7000 Spirotrac

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Sep 3, 2014 after 85 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: 5 generations back to K943404 (1994). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082478: Welch Allyn Cardioperfect Workstation Software (CPWS)  V 1.62, Welch Allyn, Inc. (2009) Summary page 5.
- K103530: Spirodoc, Medical International Research USA, Inc. (2011) Summary page 5.

## Most influential descendants
- K201562: Spirotrac (2020), 0 descendants of its own
- K142642: Vitalograph Model 6600 Compact (2015), 0 descendants of its own

## Indications for use
The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is 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.

Source page: https://510kreport.com/device/K141546
Methodology: https://510kreport.com/methodology