# K100687: Vitalograph Hand Held Spirometer, Model 2120

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Oct 16, 2010 after 220 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: 5 generations back to K896120 (1990). 16 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946075: Vitalograph Model 2120, Vitalograph, Inc. (1995) Summary page 1.
- K092324: Spiropro, Viasys Healthcare GmbH (2009) Summary page 1.
- K051572: Koko Legend, Pulmonary Data Services, Inc. (2005) Summary page 3.

## Most influential descendants
- K200550: Vitalograph Model 2120 In2itive eDiary (2020), 2 descendants of its own
- K212938: Vitalograph Model 6000 Alpha (2022), 1 descendant of its own
- K142812: Vitalograph Model 6800 Pneumotrac (2015), 1 descendant of its own
- K251777: MESI mTABLET SPIRO (2026), 0 descendants of its own
- K160253: Vitalograph Model 6300 micro (2016), 0 descendants of its own

## Indications for use
The device is a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.

Source page: https://510kreport.com/device/K100687
Methodology: https://510kreport.com/methodology