# K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: Apr 22, 2008 after 270 days
- Product code: JEH (Plethysmograph, Volume)
- Device class: 2
- Regulation: 21 CFR 868.1760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 4 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122699: Sentrysuite Product Line (2012), 9 descendants of its own
- K133925: Vyntus/ Sentrysuite Product Line (2014), 8 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K242809: Ascent Cardiorespiratory Diagnostic Software (2024), 1 descendant of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K072061
Methodology: https://510kreport.com/methodology