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 Nov 4, 1996 as substantially equivalent to K955234 (Monaghan Medical Corp., 1996) after an 88-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Nov 4, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K926307 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK926307 Peak Flow MeterMonaghan Medical Corp. · 1993
- 1 generation backK955234 Trupeak Peak Flow MeterMonaghan Medical Corp. · 1996
- This deviceK963095 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 1 of 1 · See all- K082899Dynamipeak Peak Flow MeterDynamitech Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926307 | Peak Flow Meter | Monaghan Medical Corp. | 1993 | — |
| −1 | K955234 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | 1996 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K955234 | Trupeak Peak Flow MeterSummary page 1…ary Name: TruPeak Peak Flow Meter Device Classification name: Peak Flow Meter for Spirometry, 73 BZH Legally Marketed Device Identity: TruPeak Peak Flow Meter, 510(k) #955234 Device Description: The TruPeak Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expirator… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082899 | Dynamipeak Peak Flow Meter | 2009 | 0 |
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082899 (Dynamitech Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K955234.
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/K963095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963095: 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/K963095
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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