510(k) · Cleared
ClearedTrupeak 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 Mar 18, 1996 as substantially equivalent to K926307 (Monaghan Medical Corp., 1993) after a 125-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Mar 18, 1996
- Review
- 125 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926307 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK926307 Peak Flow MeterMonaghan Medical Corp. · 1993
- This deviceK955234 Trupeak Peak Flow MeterMonaghan Medical Corp. · 1996
- Descendant · cites it directly · 1 of its ownK963095 Trupeak Peak Flow MeterMonaghan Medical Corp. · 1996
- Descendant · cites it directly · 0 of its ownK082899 Dynamipeak Peak Flow MeterDynamitech Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926307 | Peak Flow Meter | Monaghan Medical Corp. | 1993 | — |
| 0 (this device) | K955234 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | 1996 | — |
| +1 | K963095 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | 1996 | — |
| +1 | K082899 | Dynamipeak Peak Flow Meter | Dynamitech Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2009 | 1 | 0 |
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 |
|---|---|---|---|
| * | K926307 | Peak Flow MeterSummary page 1…tary Name: TruPeak Peak Flow Meter Device Classification name: Peak Flow Meter for Spirometry, 73 BZH Legally Marketed Device Identity: TruZone Peak Flow Meter, 510(k) #926307 Device Description: The TruPeak Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expirator… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K955234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955234: Trupeak Peak Flow Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955234
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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