# K031102: Microlab Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Micro Direct, Inc.
- Decided: Dec 1, 2003 after 238 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Micro Medical MicroDL Diarycard Spirometer: named in the summary without a submission number

## Most influential descendants
- K090646: Cardiotech Spirometry System, Model GT-105 (2009), 1 descendant of its own
- K201493: Spirometer (2021), 0 descendants of its own
- K141936: Microblab, Microloop (2014), 0 descendants of its own
- K113096: Micro I (2012), 0 descendants of its own
- K080299: Respifit S, Model RS-LR1001004 (2009), 0 descendants of its own

## Indications for use
The Microlab 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. 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.

Source page: https://510kreport.com/device/K031102
Methodology: https://510kreport.com/methodology