# K080734: Flowscreen, Flowscreen/Corscreen, Flowscreen CT

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: Jun 26, 2008 after 104 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
Longest line of descent: 2 generations back to K002074 (2000). 3 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K062011: Modification to Flowscreen, Viasys Healthcare GmbH (2007) Summary page 2.
- K070614: Corscreen, Viasys Healthcare GmbH (2007) Summary page 2.

## Most influential descendants
- K082539: Masterscope, Masterscope Ecg, Masterscope CT (2008), 9 descendants of its own
- K091505: COR12+ (2009), 6 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K202754: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (2021), 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 FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen / FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel). The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient. Federal U.S. law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K080734
Methodology: https://510kreport.com/methodology