510(k) · Cleared
ClearedMicrolife Digital Peak Flow Meter, Model PF200B (PF200B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Corporation · BZH Meter, Peak Flow, Spirometry
Cleared on Jun 23, 2026 as substantially equivalent to K040723 (Microlife Intellectual Property GmbH, 2004) after a 270-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jun 23, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943678 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK943678 Electronic Flow MeterVitalograph, Inc. · 1995
- 3 generations backK982995 Accutrax, Model EPF840Korr Medical Technologies, Inc. · 1998
- 2 generations backK031024 Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp. · 2003
- 1 generation backK040723 Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models…Microlife Intellectual Property GmbH · 2004
- This deviceK253180 Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943678 | Electronic Flow Meter | Vitalograph, Inc. | 1995 | — |
| −3 | K982995 | Accutrax, Model EPF840 | Korr Medical Technologies, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Summary page 5…Name: Peak-flow meter for spirometry. Regulatory Class: II Product Code: BZH 3. Information for the 510(k) Cleared Device (Predicate Device): K040723: Microlife Electronic Peak Flow Meter with PEF and FEV1, Models PF- 100 and PF-100-1 (with software), K040723, Microlife Int… | 2004 |
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 31 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K040723.
How does its category compare?
All BZH devicesBZH Meter, Peak Flow, Spirometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Microlife Digital Peak Flow Meter (Model PF200B) is intended for monitoring Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) for patient home use. The device is designed for pediatric (≥5 years of age) to adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253180: Microlife Digital Peak Flow Meter, Model PF200B (PF200B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253180
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026