510(k) · Cleared
ClearedSpirolab, Spirolab II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mir Medical Intl. Research Srl · BZG Spirometer, Diagnostic
Cleared on Mar 16, 2006 as substantially equivalent to K013812 (Sdi Diagnostics, Inc., 2002) after a 220-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 220 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013812 (2002). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013812 Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
- This deviceK052140 Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006
- Descendant · cites it directly · 5 of its ownK082766 Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
- Descendant · 2 generations on · 4 of its ownK122384 MinispirMir Medical Intl. Research Srl · 2012
- Descendant · 3 generations on · 3 of its ownK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
- Descendant · 5 generations on · 1 of its ownK161295 MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008 · cites it directly5descendants
- K122384MinispirMir Medical Intl. Research Srl · 2012 · 2 generations on4descendants
- K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014 · 3 generations on3descendants
- K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015 · 4 generations on2descendants
- K161295MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013812 | Spirolab II, Model 29 | Sdi Diagnostics, Inc. | 2002 | — |
| 0 (this device) | K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research Srl | 2006 | — |
| +1 | K082766 | Modification to Minispir, Spirolab Iii | Mir Medical Intl. Research Srl | 2008 | — |
| +2 | K122384 | Minispir | Mir Medical Intl. Research Srl | 2012 | — |
| +3 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +4 | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
| +5 | K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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 |
|---|---|---|---|
| * | K013812 | Spirolab II, Model 29 Our reading of the summary gave K012812, FDA’s number for Carotid Guiding Sheath (Terumo Medical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SDI Spirolab II”. | 2002 |
What descends from it? (7)
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?
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 and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052140: Spirolab, Spirolab II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052140
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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