510(k) · Cleared
ClearedMicroblab, Microloop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion Germany 234 GmbH · BZG Spirometer, Diagnostic
Cleared on Dec 29, 2014 as substantially equivalent to K031102 (Micro Direct, Inc., 2003) and 1 other predicate after a 165-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 29, 2014
- Review
- 165 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000648 (2000). 7 ancestors in all, the oldest K980876 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000648 | Spiro Pro | Erich Jaeger GmbH | 2000 | — |
| −2 | K031515 | Spiropro SPO2 | Viasys Healthcare GmbH | 2003 | — |
| −1 | K092324 | Spiropro | Viasys Healthcare GmbH | 2009 | — |
| 0 (this device) | K141936 | Microblab, Microloop | Carefusion Germany 234 GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K031102 | Microlab SpirometerSummary page 5…73 Anesthesiology Part 868 Code BZG 74 Cardiovascular Part 870 Code DQA 5.8 Reason for Premarket Notification • modification to existing MicroLab K031102 • SPIDA5 software will be superseded by SPCS (Spirometry PC Software) • new housing & display, optional als… | 2003 |
| * | K092324 | SpiroproSummary page 5…Ipod® sensor 5.9 Legally predicate marketed devices • Microlab Spirometer K031102 Code BZG • SpiroPro K092324 Code BTY, DQA 5.10 Predicate Device Company • CareFusion • Viasys (now CareFusion) 5.11 D… | 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 14 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K031102.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MicroLab / MicroLoop 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 and for pulse oximetry measurements. 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.
The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141936: Microblab, Microloop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141936
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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