510(k) · Cleared
ClearedMSA100BT 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 6, 2017 as substantially equivalent to K133975 (Beijing M&B Electronic Instruments Co., Ltd., 2014) after a 249-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- Oct 6, 2017
- Review
- 249 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K133975 (2014). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK133975 MSA100 Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. · 2014
- This deviceK170281 MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK191239 Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK230423 Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK203196 Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd. · 2019 · cites it directly1descendant
- K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd. · 2024 · cites it directly0descendants
- K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K133975 | MSA100 Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2014 | — |
| 0 (this device) | K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017 | — |
| +1 | K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019 | — |
| +1 | K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024 | — |
| +2 | K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133975 | MSA100 Peak Flow MeterSummary page 4…ion number 868.1860 Peak-flow meter for spirometry Regulation Class: II Product Code: BZH Meter, Peak Flow, Spirometry 3. PREDICATE DEVICE K133975, MSA100 Peak Flow Meter This predicate legally marketed device has not been subject to a design-related recall. No reference devi… | 2014 |
What descends from it? (3)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K191239 (Guangzhou Homesun Medical Technology Co., Ltd., 2019) has gone furthest, with 1 descendant 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. 2017, 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/K170281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170281: MSA100BT 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/K170281
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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