510(k) · Cleared
ClearedPulmonary Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph, Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on Feb 13, 1979 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 13, 1979
- Review
- 92 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK781922 Pulmonary MonitorVitalograph, Ltd. · 1979
- Descendant · cites it directly · 3 of its ownK030586 MicropeakMicro Direct, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK172804 Besmed Peak Flow MeterBesmed Health Business Corp · 2018
- Descendant · 2 generations on · 0 of its ownK101380 RxpeakflowNoble Marketing · 2010
- Descendant · 2 generations on · 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 5 of 5 · See all- K030586MicropeakMicro Direct, Inc. · 2003 · cites it directly3descendants
- K172804Besmed Peak Flow MeterBesmed Health Business Corp · 2018 · cites it directly0descendants
- K101380RxpeakflowNoble Marketing · 2010 · 2 generations on0descendants
- K091412Clean Peak Flow MeterViasys Healthcare GmbH · 2009 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K781922 | Pulmonary Monitor | Vitalograph, Ltd. | 1979 | — |
| +1 | K030586 | Micropeak | Micro Direct, Inc. | 2003 | — |
| +1 | K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018 | — |
| +2 | K101380 | Rxpeakflow | Noble Marketing | 2010 | — |
| +2 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K030586 (Micro Direct, Inc., 2003) has gone furthest, with 3 descendants of its own.
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/K781922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K781922: Pulmonary Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781922
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026