510(k) · Cleared
ClearedSmart One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mir Medical International Research · BZH Meter, Peak Flow, Spirometry
Cleared on Aug 1, 2018 as substantially equivalent to K040723 (Microlife Intellectual Property GmbH, 2004) after a 37-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 1, 2018
- Review
- 37 days
- Class
- Class II
- Product code
- BZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943678 (1995). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK181666 Smart OneMir Medical International Research · 2018
- Descendant · cites it directly · 1 of its ownK193311 AlunaKnox Medical Diagnostics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK232588 Aluna 2Knox Medical Diagnostics · 2024
- Descendant · cites it directly · 0 of its ownK200832 Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView 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) | K181666 | Smart One | Mir Medical International Research | 2018 | — |
| +1 | K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020 | — |
| +2 | K232588 | Aluna 2 | Knox Medical Diagnostics | 2024 | — |
| +1 | K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Summary page 4…rade Name: MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) 510(k) number: K040723 Regulation Number 868.1860 Product Code BZH 4. Description of the device: Smart One is a pocket-sized system for monit… | 2004 |
| † | K130784 | Spirotel | 2013 |
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?
- The line of descent spans 23 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.
- Of its descendants, K193311 (Knox Medical Diagnostics, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 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. 2018, 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?
Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181666: Smart One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181666
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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