# K090646: Cardiotech Spirometry System, Model GT-105

- Pathway: 510(k) (Traditional)
- Applicant: Chest M.I., Inc.
- Decided: Jul 23, 2009 after 134 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: 2 generations back to K944762 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022103: Puritan-Bennett 700 Renaissance II Spirometry System, Puritan Bennett Corp. (2002) Summary page 1.
- K031102: Microlab Spirometer, Micro Direct, Inc. (2003) Summary page 1.

## Most influential descendants
- K201493: Spirometer (2021), 0 descendants of its own

## Indications for use
The CardioTech Spirometry System, Model GT-105, is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health environments.

Source page: https://510kreport.com/device/K090646
Methodology: https://510kreport.com/methodology