# K123945: Strive Dual Zone Peak Flow Meter

- Pathway: 510(k) (Traditional)
- Applicant: Monaghan Medical Corp.
- Decided: Apr 17, 2013 after 117 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: 1 generation back to K023097 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023097: Truezone Peak Flow Meter, Monaghan Medical Corp. (2003) Summary page 1.

## Indications for use
The Striverh Dual Zone PFM is a monitoring device that measures Peak Expiratory Plow (PEP) generated by the patient during a forced exhalation maneuver. The device will monitor the PEP of patients whose doses of medication are dependent upon a measured obstruction in PEF. The Seirivl Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

Source page: https://510kreport.com/device/K123945
Methodology: https://510kreport.com/methodology