# K970507: Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Medical, Inc.
- Decided: Jun 13, 1997 after 123 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 intended use of IMI Peak Flow Meter is for Hospital Respiratory Therapy Departments, and home monitoring used by the Asthma patient as prescribed by the physician. The device is for single patient use. However, the home patient can reuse the instrument himself after cleaning. The device is non-sterile. The device is for prescription use. See package lable under Section 3, page 4. The device is not MR1 compatible.

Source page: https://510kreport.com/device/K970507
Methodology: https://510kreport.com/methodology