# K113096: Micro I

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Apr 13, 2012 after 177 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: 4 generations back to K901057 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031102: Microlab Spirometer, Micro Direct, Inc. (2003) Summary page 2.
- K100928: Micro Diary Spirometer, Viasys Respiratory Care, Inc. (2011) Summary page 2.

## Indications for use
The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatric and adult patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.

Source page: https://510kreport.com/device/K113096
Methodology: https://510kreport.com/methodology