510(k) · Cleared
ClearedStrive Dual Zone Peak Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monaghan Medical Corp. · BZH Meter, Peak Flow, Spirometry
Cleared on Apr 17, 2013 as substantially equivalent to K023097 (Monaghan Medical Corp., 2003) after a 117-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Apr 17, 2013
- Review
- 117 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023097 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023097 Truezone Peak Flow MeterMonaghan Medical Corp. · 2003
- This deviceK123945 Strive Dual Zone Peak Flow MeterMonaghan Medical Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023097 | Truezone Peak Flow Meter | Monaghan Medical Corp. | 2003 | — |
| 0 (this device) | K123945 | Strive Dual Zone Peak Flow Meter | Monaghan Medical Corp. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZH device
- #1 K252802 Peak Flow Meter (PF-10(BR-PEF231))score 13.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023097 | Truezone Peak Flow MeterSummary page 1…ion Product Code: BZH 3. Legally Marketed Predicate Device Device Trade Name: TruZone® Peak Flow Meter 5 10O(k) Number: K023097 Manufacturer: Monaghan Medical Corporation 4. Device Description The Strivem Dual Zone Peak Flow… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · BZH
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZH
371in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZH
No recall names BZH since 2007.
Adverse event reports per year · BZH
1in 2015
MAUDE reports naming product code BZH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 115 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 371 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123945 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123945: Strive Dual Zone Peak Flow Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123945
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026