510(k) · Cleared
ClearedElectronic Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph, Inc. · BZH Meter, Peak Flow, Spirometry
Cleared on Dec 14, 1995 after a 506-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 21 later devices descend from it.
- Decided
- Dec 14, 1995
- Review
- 506 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- Descendant · cites it directly · 20 of its ownK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- Descendant · 2 generations on · 10 of its ownK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- Descendant · 2 generations on · 9 of its ownK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- Descendant · 2 generations on · 8 of its ownK022276 KokomateFerraris Respiratory, Inc. · 2002
- Descendant · 3 generations on · 7 of its ownK051572 Koko LegendPulmonary Data Services, Inc. · 2005
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K982995Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998 · cites it directly20descendants
- K031024Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003 · 2 generations on10descendants
- K040723Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Microlife Intellectual Property GmbH · 2004 · 2 generations on9descendants
- K022276KokomateFerraris Respiratory, Inc. · 2002 · 2 generations on8descendants
- K051572Koko LegendPulmonary Data Services, Inc. · 2005 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| +1 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| +2 | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| +2 | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| +2 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| +3 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982995 | Accutrax, Model EPF840 | 1998 | 20 |
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, K982995 (Korr Medical Technologies, Inc., 1998) has gone furthest, with 20 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/K943678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943678: Electronic 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/K943678
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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