510(k) · Cleared
ClearedMasterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Healthcare GmbH · JEH Plethysmograph, Volume
Cleared on Apr 22, 2008 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 14 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Apr 22, 2008
- Review
- 270 days
- Class
- Class II
- Product code
- JEH
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- This deviceK072061 Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyViasys Healthcare GmbH · 2008
- Descendant · cites it directly · 9 of its ownK122699 Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012
- Descendant · 2 generations on · 8 of its ownK133925 Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014
- Descendant · 3 generations on · 5 of its ownK150810 Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK242809 Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024
- Descendant · 4 generations on · 1 of its ownK181524 Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with…Vyaire Medical, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K150810 Vyntus / SentrySuite Product Line3 generations on · 2015
Most influential descendants
Showing 5 of 13 · See all- K122699Sentrysuite Product LineCarefusion Germany 234 GmbH · 2012 · cites it directly9descendants
- K133925Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH · 2014 · 2 generations on8descendants
- K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH · 2015 · 3 generations on5descendants
- K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation · 2024 · 3 generations on1descendant
- K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc. · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body | Viasys Healthcare GmbH | 2008 | — |
| +1 | K122699 | Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2012 | — |
| +2 | K133925 | Vyntus/ Sentrysuite Product Line | Carefusion Germany 234 GmbH | 2014 | — |
| +3 | K150810 | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | 2015 | Class I |
| +3 | K242809 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | 2024 | — |
| +4 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with… | Vyaire Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 JEH device
- #1 K240706 PowerCube+ Series (PowerCube Body+)…score 8.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 134 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 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K122699 (Carefusion Germany 234 GmbH, 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JEH devicesJEH Plethysmograph, Volume: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JEH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JEH
Too few JEH 510(k)s in any year since 2007 to give a median.
Recalls per year · JEH
No recall names JEH since 2007.
Adverse event reports per year · JEH
1in 2024
MAUDE reports naming product code JEH, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data/information and supports help for a diagnosis. MasterScreen PFT CT (Clinical Trial version) includes…
Read the full statement (140 words)
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data/information and supports help for a diagnosis.
MasterScreen PFT CT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel). MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.
Measurements will be performed under the direction of a physician in the clinic, doctor's 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 MS-PFT Body is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072061
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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