510(k) · Cleared
ClearedMicrolife Electronic Peak Flow Monitor, Model PF-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Corp. · BZH Meter, Peak Flow, Spirometry
Cleared on Nov 14, 2003 as substantially equivalent to K982995 (Korr Medical Technologies, Inc., 1998) after a 228-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it.
- Decided
- Nov 14, 2003
- Review
- 228 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943678 (1995). 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 1 generation backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- This deviceK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- Descendant · cites it directly · 9 of its ownK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- Descendant · 2 generations on · 4 of its ownK152276 Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK181666 Smart OneMir Medical International Research · 2018
- Descendant · 3 generations on · 1 of its ownK193311 AlunaKnox Medical Diagnostics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK253180 Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040723Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Microlife Intellectual Property GmbH · 2004 · cites it directly9descendants
- K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc. · 2016 · 2 generations on4descendants
- K181666Smart OneMir Medical International Research · 2018 · 2 generations on3descendants
- K193311AlunaKnox Medical Diagnostics, Inc. · 2020 · 3 generations on1descendant
- K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −1 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| 0 (this device) | K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100 | Microlife Corp. | 2003 | — |
| +1 | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… | Microlife Intellectual Property GmbH | 2004 | — |
| +2 | K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016 | — |
| +2 | K181666 | Smart One | Mir Medical International Research | 2018 | — |
| +3 | K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020 | — |
| +2 | K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K982995 | Accutrax, Model EPF840Summary page 1…the Device: Microlife Electronic Peak Flow Monitor, Model PF-100 Predicate Device Information: ACCUTRAX Electronic Peak Flow Meter, Model EPF840, K#982995, Korr Medical Technologies, Inc., Salt Lake City, Utah Device Description: The Microlife Electronic Peak Flow… | 1998 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1… | 2004 | 9 |
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 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040723 (Microlife Intellectual Property GmbH, 2004) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K982995.
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) for patient home use. The device is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the device is used to monitor lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advice is required to understand the meaning and importance of the measurements reported by the device and how to decide on an appropriate treatment plan. This treatment plan will tell the patient what action to take when there are changes in their PEF measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031024: Microlife Electronic Peak Flow Monitor, Model PF-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031024
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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