# K202754: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

- Pathway: 510(k) (Traditional)
- Applicant: Eresearchtechnology GmbH
- Decided: Jan 28, 2021 after 129 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: 4 generations back to K002074 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082539: Masterscope, Masterscope Ecg, Masterscope CT, Cardinal Health Germany 234 GmbH (2008) Summary page 5.

## Most influential descendants
- K223629: SpiroSphere, SpiroSphereECG, CardioSphere (2024), 0 descendants of its own

## Indications for use
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It 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. A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope/MasterScope ECG represent partial quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements. It can be used by physicians in the office or hospital. The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.

Source page: https://510kreport.com/device/K202754
Methodology: https://510kreport.com/methodology