# K141936: Microblab, Microloop

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Dec 29, 2014 after 165 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: 3 generations back to K000648 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 5.
- K092324: Spiropro, Viasys Healthcare GmbH (2009) Summary page 5.

## Indications for use
The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient’s lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments. The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.

Source page: https://510kreport.com/device/K141936
Methodology: https://510kreport.com/methodology