510(k) · Cleared
ClearedClean Peak Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · BZH Meter, Peak Flow, Spirometry
Cleared on Aug 21, 2009 as substantially equivalent to K030586 (Micro Direct, Inc., 2003) after a 100-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Aug 21, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K781922 (1979). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K030586 | MicropeakSummary page 2…odification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm" 5.9 Legally predicate marketed devices MicroPeak K030586 / Code BZH 5.10 Predicate Device Company Cardinal Health U. K. 232 Limited (Owned by Cardinal Health Inc.) 5.11… | 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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 24.5 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K030586.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 - 380 liters/minutes
Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes
Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use:
Places where a patient may require the measurement of their peak expriatory flow rate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091412: Clean 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/K091412
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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