510(k) · Cleared
ClearedDynamipeak Peak Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynamitech Medical, Inc. · BZH Meter, Peak Flow, Spirometry
Cleared on Mar 10, 2009 as substantially equivalent to K030586 (Micro Direct, Inc., 2003) and 3 other predicates after a 161-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 10, 2009
- Review
- 161 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K926307 (1993). 5 ancestors in all, the oldest K781922 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK926307 Peak Flow MeterMonaghan Medical Corp. · 1993
- 2 generations backK955234 Trupeak Peak Flow MeterMonaghan Medical Corp. · 1996
- 1 generation backK963095 Trupeak Peak Flow MeterMonaghan Medical Corp. · 1996
- This deviceK082899 Dynamipeak Peak Flow MeterDynamitech Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926307 | Peak Flow Meter | Monaghan Medical Corp. | 1993 | — |
| −2 | K955234 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | 1996 | — |
| −1 | K963095 | Trupeak Peak Flow Meter | Monaghan Medical Corp. | 1996 | — |
| 0 (this device) | K082899 | Dynamipeak Peak Flow Meter | Dynamitech Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 2003 | 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? (5)
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…uivalence of the DynamiTech Medical, Inc. DynamiPeak T M Peak Flow Meter to five predicate devices: (1) Micro Direct, Inc., MICROPEAK Peak Flow Meter, K030586, SE Date: 08/27/2003. (2) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K963095, SE Date:… | 2003 |
| * | K963095 | Trupeak Peak Flow MeterSummary page 2…(1) Micro Direct, Inc., MICROPEAK Peak Flow Meter, K030586, SE Date: 08/27/2003. (2) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K963095, SE Date: 11/04/1996. (3) Galemed Corp., GALEMED Peak Flow Meter, Models 3754/3752, SE Date:… | 1996 |
| * | K955234 | Trupeak Peak Flow MeterSummary page 2…(3) Galemed Corp., GALEMED Peak Flow Meter, Models 3754/3752, SE Date: 04/03/2003. (4) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K955234, SE Date: 11/14/1996. (5) Vitalograph Ltd., PULMONARY MONITOR, K781922, SE Date: 02/13/1979.… | 1996 |
| * | K781922 | Pulmonary MonitorSummary page 2…/2003. (4) Monaghan Medical Corp., TRUPEAK Peak Flow Meter, K955234, SE Date: 11/14/1996. (5) Vitalograph Ltd., PULMONARY MONITOR, K781922, SE Date: 02/13/1979. 0012A(revised 02/03/2009) DynamiT… | 1979 |
| * | — | GALEMED Peak Flow Meter, Models 3754/3752 Named without a submission number |
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 16 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 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 DynamiPeak TM Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082899: Dynamipeak 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/K082899
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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