# K142642: Vitalograph Model 6600 Compact

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Jun 30, 2015 after 286 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 K896120 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 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 5.
- K100687: Vitalograph Hand Held Spirometer, Model 2120, Vitalograph (Ireland), Ltd. (2010) Summary page 5.

## Indications for use
The Vitalograph Model 6600 COMPACT 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 adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Source page: https://510kreport.com/device/K142642
Methodology: https://510kreport.com/methodology