510(k) · Cleared
ClearedMicrolife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Intellectual Property GmbH · BZH Meter, Peak Flow, Spirometry
Cleared on Jun 10, 2004 as substantially equivalent to K031024 (Microlife Corp., 2003) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.
- Decided
- Jun 10, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943678 (1995). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 2 generations backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- 1 generation backK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- This deviceK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- Descendant · cites it directly · 4 of its ownK152276 Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK181666 Smart OneMir Medical International Research · 2018
- Descendant · 2 generations on · 1 of its ownK193311 AlunaKnox Medical Diagnostics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253180 Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK232588 Aluna 2Knox Medical Diagnostics · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016 · cites it directly4descendants
- K181666Smart OneMir Medical International Research · 2018 · cites it directly3descendants
- K193311AlunaKnox Medical Diagnostics, Inc. · 2020 · 2 generations on1descendant
- K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026 · cites it directly0descendants
- K232588Aluna 2Knox Medical Diagnostics · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −2 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| −1 | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| 0 (this device) | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| +1 | K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016 | — |
| +1 | K181666 | Smart One | Mir Medical International Research | 2018 | — |
| +2 | K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020 | — |
| +1 | K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026 | — |
| +3 | K232588 | Aluna 2 | Knox Medical Diagnostics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | 2003 |
| * | K982995 | Accutrax, Model EPF840Summary page 4…024, Microlife Intellectual Property Gm~bH Accutrax Electronic Peak Flow Meter, Model EPF84O, Korr Medical Technologies, Inc., Salt Lake City, Utah, K#982995 4. Device Description: The Microlife Electronic Peak Flow Monitor, Model PF-100, comprises a hand held micropr… | 1998 |
What descends from it? (9)
4 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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152276 (Sparo, Inc., 2016) has gone furthest, with 4 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 | — |
What is it indicated for?
This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040723
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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