510(k) · Cleared
ClearedMicrolab Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Direct, Inc. · BZG Spirometer, Diagnostic
Cleared on Dec 1, 2003 after a 238-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 1, 2003
- Review
- 238 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK031102 Microlab SpirometerMicro Direct, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK090646 Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK201493 SpirometerMehow Innovative, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK141936 Microblab, MicroloopCarefusion Germany 234 GmbH · 2014
- Descendant · cites it directly · 0 of its ownK113096 Micro ICarefusion Germany 234 GmbH · 2012
- Descendant · cites it directly · 0 of its ownK080299 Respifit S, Model RS-LR1001004Eumedics Medizintechnik Und Marketing GmbH · 2009
Most influential descendants
Showing 5 of 5 · See all- K090646Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 2009 · cites it directly1descendant
- K201493SpirometerMehow Innovative, Ltd. · 2021 · 2 generations on0descendants
- K141936Microblab, MicroloopCarefusion Germany 234 GmbH · 2014 · cites it directly0descendants
- K113096Micro ICarefusion Germany 234 GmbH · 2012 · cites it directly0descendants
- K080299Respifit S, Model RS-LR1001004Eumedics Medizintechnik Und Marketing GmbH · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031102 | Microlab Spirometer | Micro Direct, Inc. | 2003 | — |
| +1 | K090646 | Cardiotech Spirometry System, Model GT-105 | Chest M.I., Inc. | 2009 | — |
| +2 | K201493 | Spirometer | Mehow Innovative, Ltd. | 2021 | — |
| +1 | K141936 | Microblab, Microloop | Carefusion Germany 234 GmbH | 2014 | — |
| +1 | K113096 | Micro I | Carefusion Germany 234 GmbH | 2012 | — |
| +1 | K080299 | Respifit S, Model RS-LR1001004 | Eumedics Medizintechnik Und Marketing GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | Micro Medical MicroDL Diarycard Spirometer Named without a submission number |
What descends from it? (5)
4 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?
- Of its descendants, K090646 (Chest M.I., Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Microlab spirometer is intended, for prescription use only, 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 (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031102: Microlab Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031102
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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