510(k) · Cleared
ClearedMiniBox +
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 Oct 21, 2016 as substantially equivalent to K141793 (Pulmone Advanced Medical Devices, Ltd., 2015) and 1 other predicate after a 165-day review. Its family tree reaches back 6 generations to 2002. 1 later device descends from it.
- Decided
- Oct 21, 2016
- Review
- 165 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K013812 (2002). 9 ancestors in all, the oldest K942211 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK013812 Spirolab II, Model 29Sdi Diagnostics, Inc. · 2002
- 5 generations backK052140 Spirolab, Spirolab IIMir Medical Intl. Research Srl · 2006
- 4 generations backK082766 Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl · 2008
- 3 generations backK122384 MinispirMir Medical Intl. Research Srl · 2012
- 2 generations backK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- 1 generation backK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
- This deviceK161295 MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK240293 STSTechbopulm, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240293STSTechbopulm, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013812 | Spirolab II, Model 29 | Sdi Diagnostics, Inc. | 2002 | — |
| −5 | K052140 | Spirolab, Spirolab II | Mir Medical Intl. Research Srl | 2006 | — |
| −4 | K082766 | Modification to Minispir, Spirolab Iii | Mir Medical Intl. Research Srl | 2008 | — |
| −3 | K122384 | Minispir | Mir Medical Intl. Research Srl | 2012 | — |
| −2 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| −1 | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
| 0 (this device) | K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141793 | Pulmone Miniboxpft 2.0Summary page 4…Predicate Devices: Primary Predicate: PulmOne MiniBoxPFT™ 2.0 510(k) Number –K141793 Secondary Predicate: ZAN LUNG-FUNCTION LAB… | 2015 |
| * | K052328 | Zan Lung-Function LabSummary page 4…Secondary Predicate: ZAN LUNG-FUNCTION LAB 510(k) Number - K052328 Application Correspondent: Dr. Susan Alpert SFA Consulting, LLC… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240293 | STS | 2024 | 0 |
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 2.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K240293 (Techbopulm, Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161295: MiniBox +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161295
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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