510(k) · Cleared
ClearedMasterscreen Pneumo & Masterscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Aug 14, 2007 after a 47-day review. The FDA summary names no predicate by number. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Aug 14, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceK071753 Masterscreen Pneumo & MasterscopeViasys Healthcare GmbH · 2007
- Descendant · cites it directly · 11 of its ownK111053 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011
- Descendant · 2 generations on · 9 of its ownK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- Descendant · cites it directly · 9 of its ownK082539 Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008
- Descendant · 3 generations on · 8 of its ownK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- Descendant · 2 generations on · 6 of its ownK091505 COR12+Viasys Healthcare GmbH · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line2 generations on · 2015
Most influential descendants
Showing 5 of 17 · See all- K111053Sentrysuite Product LineCarefusion Germany 234 GmbH · 2011 · cites it directly11descendants
- K122699Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012 · 2 generations on9descendants
- K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH · 2008 · cites it directly9descendants
- K133925Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014 · 3 generations on8descendants
- K091505COR12+Viasys Healthcare GmbH · 2009 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071753 | Masterscreen Pneumo & Masterscope | Viasys Healthcare GmbH | 2007 | — |
| +1 | K111053 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2011 | — |
| +2 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| +1 | K082539 | Masterscope, Masterscope Ecg, Masterscope CT | Cardinal Health Germany 234 GmbH | 2008 | — |
| +3 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| +2 | K091505 | COR12+ | Viasys Healthcare GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111053 (Carefusion Germany 234 GmbH, 2011) has gone furthest, with 11 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. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Masterscreen Pneumo / Masterscope is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements. Mostly it will be used for COPD and Asthma patients. Measurements will be performed under the direction of a physician in the clinic, doctors office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. The Masterscreen Pneumo / Masterscope is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071753 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071753: Masterscreen Pneumo & Masterscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071753
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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