# K071753: Masterscreen Pneumo & Masterscope

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: Aug 14, 2007 after 47 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 3 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K111053: Sentrysuite Product Line (2011), 11 descendants of its own
- K122699: Sentrysuite Product Line (2012), 9 descendants of its own
- K082539: Masterscope, Masterscope Ecg, Masterscope CT (2008), 9 descendants of its own
- K133925: Vyntus/ Sentrysuite Product Line (2014), 8 descendants of its own
- K091505: COR12+ (2009), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071753
Methodology: https://510kreport.com/methodology