510(k) · Cleared
ClearedZan Lung-Function Lab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zan Messgerate GmbH · BZC Calculator, Pulmonary Function Data
Cleared on Dec 22, 2005 as substantially equivalent to K992743 (Collins Medical, Inc., 1999) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 1994. 4 later devices descend from it.
- Decided
- Dec 22, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- BZC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942211 (1994). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- This deviceK052328 Zan Lung-Function LabZan Messgerate GmbH · 2005
- Descendant · cites it directly · 3 of its ownK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK141793 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 4 of 4 · See all- K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014 · cites it directly3descendants
- K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015 · 2 generations on2descendants
- K161295MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016 · cites it directly1descendant
- K240293STSTechbopulm, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| 0 (this device) | K052328 | Zan Lung-Function Lab | Zan Messgerate GmbH | 2005 | — |
| +1 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K992743 | Collins CPLSummary page 1…tor, 21 CFR 868.1880; Class II Product code: 73-BZC Predicate Devices Trade Name: CPL Pulmonary Function Test System 510(k) Number: K992743 Manufacturer: Ferraris Respiratory, Inc. Trade Name: Vmax Series Diagnostic Instruments 510(k) Numb… | 1999 |
| * | K942211 | VMAX229 Series Pulmonary/Metabolic SystemsSummary page 1…510(k) Number: K992743 Manufacturer: Ferraris Respiratory, Inc. Trade Name: Vmax Series Diagnostic Instruments 510(k) Number: K942211 Manufacturer: SensorMedics, Inc. Device Description The ZAN Lung-Function Lab (LFL) is a full-featured, PC-bas… | 1994 |
What descends from it? (4)
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 BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including spirometry, airway strength and compliance, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, rehabilitation, performance enhancement, and other related activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052328 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052328: Zan Lung-Function Lab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052328
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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