# K963089: Truzone Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Monaghan Medical Corp.
- Decided: Nov 6, 1996 after 90 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
Longest line of descent: 2 generations back to K926307 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926307: Peak Flow Meter, Monaghan Medical Corp. (1993) Summary page 1.
- K955262: Truzone Peak Flow Meter, Monaghan Medical Corp. (1996) Summary page 1.

Source page: https://510kreport.com/device/K963089
Methodology: https://510kreport.com/methodology