# K223629: SpiroSphere, SpiroSphereECG, CardioSphere

- Pathway: 510(k) (Traditional)
- Applicant: Eresearchtechnology GmbH
- Decided: May 28, 2024 after 540 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: 5 generations back to K002074 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202754: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU, Eresearchtechnology GmbH (2021) Summary page 7.

## Indications for use
The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital. The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. With the option ECG, electrocardiographic measurements can be made under resting conditions. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use. A qualified physician has to reassess all ECG measurements. An interpretation by SpiroSphere ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the SpiroSphere ECG 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 SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The minimum age for ECG application is 4 years. It can be used by physicians in the office or hospital. With the CardioSphere, electrocardiographic measurements can be made under resting conditions. For this purpose a 12-channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use. A qualified physician has to reassess all ECG measurements. An interpretation by CardioSphere is only significant ifit is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere 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 CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment). The minimum age for ECG application is 4 years. It can be used by physicians in the office or hospital.

Source page: https://510kreport.com/device/K223629
Methodology: https://510kreport.com/methodology