510(k) · Cleared
ClearedSpirolab II, Model 29
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sdi Diagnostics, Inc. · BZG Spirometer, Diagnostic
Cleared on Feb 11, 2002 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK013812 Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK052140 Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006
- Descendant · 2 generations on · 5 of its ownK082766 Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
- Descendant · 3 generations on · 4 of its ownK122384 MinispirMir Medical Intl. Research Srl · 2012
- Descendant · 4 generations on · 3 of its ownK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · 5 generations on · 2 of its ownK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K052140Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006 · cites it directly7descendants
- K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008 · 2 generations on5descendants
- K122384MinispirMir Medical Intl. Research Srl · 2012 · 3 generations on4descendants
- K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014 · 4 generations on3descendants
- K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013812 | Spirolab II, Model 29 | Sdi Diagnostics, Inc. | 2002 | — |
| +1 | K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research Srl | 2006 | — |
| +2 | K082766 | Modification to Minispir, Spirolab Iii | Mir Medical Intl. Research Srl | 2008 | — |
| +3 | K122384 | Minispir | Mir Medical Intl. Research Srl | 2012 | — |
| +4 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +5 | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
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?
- Of its descendants, K052140 (Mir Medical Intl. Research Srl, 2006) has gone furthest, with 7 descendants 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 Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or technician to test lung function in people of all ages. It can be used in any setting, home, factory hospital or physician’s office.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013812: Spirolab II, Model 29.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013812
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026