# K200550: Vitalograph Model 2120 In2itive eDiary

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph Ireland, Ltd.
- Decided: Jul 27, 2020 after 146 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). 17 ancestors in all.
2 later devices descend 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)
- K100687: Vitalograph Hand Held Spirometer, Model 2120, Vitalograph (Ireland), Ltd. (2010) Summary page 4.

## Most influential descendants
- K212938: Vitalograph Model 6000 Alpha (2022), 1 descendant of its own
- K251777: MESI mTABLET SPIRO (2026), 0 descendants of its own

## Indications for use
The Vitalograph Model 2120 In2itive eDiary device is a battery-operated spirometer which measures three basic patient respiratory parameters (FVC, MVV and VC). The Vitalograph Model 2120 In2itive eDiary is a handheld spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. It is intended for Adults and pediatrics, 5 years and older. The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.

Source page: https://510kreport.com/device/K200550
Methodology: https://510kreport.com/methodology