# K020004: Clindatalink Version 1.0 for Spirometry

- Pathway: 510(k) (Traditional)
- Applicant: Compleware Corp.
- Decided: Jul 24, 2002 after 203 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 K932278 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973138: Spirocard, Qrs Diagnostic, LLC (1998) Summary page 1.

## Indications for use
The ClinDataLinkTMVersion 1.O for Spirometry is an application software that will collect spirometry data for clinical research studies in male/females, pediatrics to adults, and measure FVC, MVV, and SVC, in a hospital, clinic, or home use environment. Prescription device by a physician.

Source page: https://510kreport.com/device/K020004
Methodology: https://510kreport.com/methodology