510(k) · Cleared
ClearedVMAX229 Series Pulmonary/Metabolic Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Nov 22, 1994 after a 201-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Nov 22, 1994
- Review
- 201 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- Descendant · cites it directly · 4 of its ownK052328 Zan Lung-Function LabZan Messgerate GmbH · 2005
- Descendant · 2 generations on · 3 of its ownK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK120635 Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG · 2012
- Descendant · cites it directly · 3 of its ownK091428 Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010
- Descendant · 2 generations on · 2 of its ownK161534 EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K052328Zan Lung-Function LabZan Messgerate GmbH · 2005 · cites it directly4descendants
- K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014 · 2 generations on3descendants
- K120635Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG · 2012 · cites it directly3descendants
- K091428Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010 · cites it directly3descendants
- K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| +1 | K052328 | Zan Lung-Function Lab | Zan Messgerate GmbH | 2005 | — |
| +2 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +1 | K120635 | Easyone Pro Respiratory Testing Device | Ndd Medizitechnik AG | 2012 | — |
| +1 | K091428 | Easyone Pro Respiratory Analysis System | Ndd Medizitechnik AG | 2010 | — |
| +2 | K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTY? 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 146 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?
- Of its descendants, K052328 (Zan Messgerate GmbH, 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K942211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942211: VMAX229 Series Pulmonary/Metabolic Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942211
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026