510(k) · Cleared
ClearedMicropeak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Direct, Inc. · BZH Meter, Peak Flow, Spirometry
Cleared on Aug 27, 2003 as substantially equivalent to K781922 (Vitalograph, Ltd., 1979) after a 184-day review. Its family tree reaches back 1 generation to 1979. 3 later devices descend from it.
- Decided
- Aug 27, 2003
- Review
- 184 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781922 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK781922 Pulmonary MonitorVitalograph, Ltd. · 1979
- This deviceK030586 MicropeakMicro Direct, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK101380 RxpeakflowNoble Marketing · 2010
- Descendant · cites it directly · 0 of its ownK091412 Clean Peak Flow MeterViasys Healthcare GmbH · 2009
- Descendant · cites it directly · 0 of its ownK082899 Dynamipeak Peak Flow MeterDynamitech Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781922 | Pulmonary Monitor | Vitalograph, Ltd. | 1979 | — |
| 0 (this device) | K030586 | Micropeak | Micro Direct, Inc. | 2003 | — |
| +1 | K101380 | Rxpeakflow | Noble Marketing | 2010 | — |
| +1 | K091412 | Clean Peak Flow Meter | Viasys Healthcare GmbH | 2009 | — |
| +1 | K082899 | Dynamipeak Peak Flow Meter | Dynamitech Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K781922 | Pulmonary MonitorSummary page 1…Flow Intended device: Peak Flow Meter Predicate devices: Vitalograph Asmaplan+ - K781922 Device description: A peak flow meter is a device used to measure a person's peak… | 1979 |
What descends from it? (3)
3 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 | — |
What is it indicated for?
The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030586: Micropeak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030586
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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