510(k) · Cleared
ClearedSpirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mehow Innovative, Ltd. · BZG Spirometer, Diagnostic
Cleared on Jun 10, 2021 as substantially equivalent to K090646 (Chest M.I., Inc., 2009) after a 371-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 10, 2021
- Review
- 371 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944762 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- 2 generations backK022103 Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002
- 1 generation backK090646 Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 2009
- This deviceK201493 SpirometerMehow Innovative, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| −2 | K022103 | Puritan-Bennett 700 Renaissance II Spirometry System | Puritan Bennett Corp. | 2002 | — |
| −1 | K090646 | Cardiotech Spirometry System, Model GT-105 | Chest M.I., Inc. | 2009 | — |
| 0 (this device) | K201493 | Spirometer | Mehow Innovative, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 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 |
|---|---|---|---|
| * | K090646 | Cardiotech Spirometry System, Model GT-105Summary page 5…tion Submission III. PREDICATE DEVICE Predicate device CardioTech Spirometry System, Model GT-105: K090646 IV. DEVICE DESCRIPTION The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic… | 2009 |
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 27 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient’s lungs. The system is intended for use with pediatric (5 to 21 years) and adult (22 years and older) patients in hospitals, physician’s offices, laboratories, and occupational health environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201493: Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201493
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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