# K023097: Truezone Peak Flow Meter

- Pathway: 510(k) (Abbreviated)
- Applicant: Monaghan Medical Corp.
- Decided: Mar 7, 2003 after 170 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K123945: Strive Dual Zone Peak Flow Meter (2013), 0 descendants of its own

## Indications for use
The TruZoneTM Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

Source page: https://510kreport.com/device/K023097
Methodology: https://510kreport.com/methodology