# K212938: Vitalograph Model 6000 Alpha

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph Ireland, Ltd.
- Decided: Jan 26, 2022 after 133 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: 7 generations back to K896120 (1990). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200550: Vitalograph Model 2120 In2itive eDiary, Vitalograph Ireland, Ltd. (2020) Summary page 4.

## Most influential descendants
- K251777: MESI mTABLET SPIRO (2026), 0 descendants of its own

## Indications for use
The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.

Source page: https://510kreport.com/device/K212938
Methodology: https://510kreport.com/methodology