# K963035: Micro Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Micro Direct, Inc.
- Decided: Nov 1, 1996 after 88 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: 1 generation back to K901057 (1990). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901057: Spirometrics Model 2600 Miro Spirometer, Spirometrics, Inc. (1990) Summary page 1.

## Most influential descendants
- K061283: Pulmolife (2006), 3 descendants of its own
- K073155: Vitalograph Model 4000 (Asma-1 and Copd-6) (2008), 2 descendants of its own
- K965042: Microdl Diarycard Spirometer (1997), 2 descendants of its own
- K100928: Micro Diary Spirometer (2011), 1 descendant of its own
- K241843: TD-7301 Spirometer (TD-7301) (2024), 0 descendants of its own

## Indications for use
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.

Source page: https://510kreport.com/device/K963035
Methodology: https://510kreport.com/methodology