510(k) · Cleared
ClearedMSA100 Peak Flow Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing M&B Electronic Instruments Co., Ltd. · BZH Meter, Peak Flow, Spirometry
Cleared on Oct 3, 2014 after a 281-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Oct 3, 2014
- Review
- 281 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceK133975 MSA100 Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK170281 MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK191239 Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK230423 Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK203196 Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. · 2017 · cites it directly3descendants
- K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. · 2019 · 2 generations on1descendant
- K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd. · 2024 · 2 generations on0descendants
- K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133975 | MSA100 Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2014 | — |
| +1 | K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017 | — |
| +2 | K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019 | — |
| +2 | K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024 | — |
| +3 | K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040723 | FDA’s K040723 is Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170281 | MSA100BT Peak Flow Meter | 2017 | 3 |
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, K170281 (Beijing M&B Electronic Instruments Co., Ltd., 2017) 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. 2014, 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?
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. The device is intended for monitoring respiratory conditions such as asthma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133975: MSA100 Peak 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/K133975
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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