510(k) · Cleared
ClearedPulmone Minibox PFT TM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmone Advanced Medical Devices, Ltd. · BZC Calculator, Pulmonary Function Data
Cleared on May 2, 2014 as substantially equivalent to K052328 (Zan Messgerate GmbH, 2005) and 1 other predicate after a 217-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- May 2, 2014
- Review
- 217 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K013812 (2002). 7 ancestors in all, the oldest K942211 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK013812 Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
- 3 generations backK052140 Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006
- 2 generations backK082766 Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
- 1 generation backK122384 MinispirMir Medical Intl. Research Srl · 2012
- This deviceK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK161295 MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK240293 STSTechbopulm, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013812 | Spirolab II, Model 29 | Sdi Diagnostics, Inc. | 2002 | — |
| −3 | K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research Srl | 2006 | — |
| −2 | K082766 | Modification to Minispir, Spirolab Iii | Mir Medical Intl. Research Srl | 2008 | — |
| −1 | K122384 | Minispir | Mir Medical Intl. Research Srl | 2012 | — |
| 0 (this device) | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +1 | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
| +2 | K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016 | — |
| +3 | 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 |
|---|---|---|
| 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 BZC? 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 BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K052328 | Zan Lung-Function LabSummary page 1…ZAN Messgerite GmbH ZAN Lung-Function Lab 510(k) Number - K052328 Spirometry Module MIR Medical International Research… | 2005 |
| * | K122384 | MinispirSummary page 1…MIR Medical International Research Minispir 510(k) Number - K 1223 84 5.2 DEVICE DESCRIPTION The MiniBoxPFTTM[ is a table-top pulmonary function testing (PFT) device that measures both spirome… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141793 | Pulmone Miniboxpft 2.0 | 2015 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K141793 (Pulmone Advanced Medical Devices, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K052328.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PulmOne MiniBoxPFT is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT is to be used by either a physician, respiratory therapist, or technician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133051: Pulmone Minibox PFT TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133051
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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