# K965042: Microdl Diarycard Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Micro Direct, Inc.
- Decided: Jun 17, 1997 after 182 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: 2 generations back to K901057 (1990). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963035: Micro Spirometer, Micro Direct, Inc. (1996) Summary page 1.

## Most influential descendants
- K100928: Micro Diary Spirometer (2011), 1 descendant of its own
- K113096: Micro I (2012), 0 descendants of its own

## Indications for use
To measure lung functions. - FEV1, FVC, and PEF. and to effect historical serial transfer of measured test indices to PC compatible computers

Source page: https://510kreport.com/device/K965042
Methodology: https://510kreport.com/methodology