# K991412: Vitalograph Micro

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph, Inc.
- Decided: Feb 4, 2000 after 287 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vitalograph Micro Spirometer is intended to measure, FVC, FEV1, PEF and FEV1% in patients with respiratory conditions such as Asthma, COPD, etc.

Source page: https://510kreport.com/device/K991412
Methodology: https://510kreport.com/methodology