# K160253: Vitalograph Model 6300 micro

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Aug 26, 2016 after 207 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.
No later device cites it as a predicate yet.
0 of 19 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 5.
- K142812: Vitalograph Model 6800 Pneumotrac, Vitalograph (Ireland), Ltd. (2015) Summary page 5.

## Indications for use
The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

Source page: https://510kreport.com/device/K160253
Methodology: https://510kreport.com/methodology