# K062011: Modification to Flowscreen

- Pathway: 510(k) (Special)
- Applicant: Viasys Healthcare GmbH
- Decided: May 11, 2007 after 298 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.
11 later devices descend from it; 1 cites it directly.
1 of 12 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
- K080734: Flowscreen, Flowscreen/Corscreen, Flowscreen CT (2008), 10 descendants of its own
- 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

## Indications for use
The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). 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 FlowScreen is powered from 115V/6OHz wall outlets. No energy is transferred to the patient.

Source page: https://510kreport.com/device/K062011
Methodology: https://510kreport.com/methodology