510(k) · Cleared
ClearedPulmone Miniboxpft 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmone Advanced Medical Devices, Ltd. · BZG Spirometer, Diagnostic
Cleared on Mar 6, 2015 as substantially equivalent to K133051 (Pulmone Advanced Medical Devices, Ltd., 2014) after a 247-day review. Its family tree reaches back 5 generations to 2002. 2 later devices descend from it.
- Decided
- Mar 6, 2015
- Review
- 247 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K013812 (2002). 8 ancestors in all, the oldest K942211 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK013812 Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
- 4 generations backK052140 Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006
- 3 generations backK082766 Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
- 2 generations backK122384 MinispirMir Medical Intl. Research Srl · 2012
- 1 generation backK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- This deviceK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK161295 MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK240293 STSTechbopulm, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013812 | Spirolab II, Model 29 | Sdi Diagnostics, Inc. | 2002 | — |
| −4 | K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research Srl | 2006 | — |
| −3 | K082766 | Modification to Minispir, Spirolab Iii | Mir Medical Intl. Research Srl | 2008 | — |
| −2 | K122384 | Minispir | Mir Medical Intl. Research Srl | 2012 | — |
| −1 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| 0 (this device) | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
| +1 | K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016 | — |
| +2 | K240293 | STS | Techbopulm, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K133051 | Pulmone Minibox PFT TMSummary page 4…BZC Device Class: Class II Predicate Devices: PulmOne MiniBoxPFT™ 510(k) Number – K133051 5.2 DEVICE DESCRIPTION The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients whi… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161295 | MiniBox + | 2016 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K161295 (Pulmone Advanced Medical Devices, Ltd., 2016) 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. 2015, 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 PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.
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/K141793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141793: Pulmone Miniboxpft 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141793
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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