# K051126: Cardioscope Sonoplus 3000

- Pathway: 510(k) (Traditional)
- Applicant: Pulsonic Ag, Medical Technology
- Decided: May 19, 2005 after 16 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K954066 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990809: Cadiscope Electronic Stethoscope, Caditec AG (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K980105: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System") This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic. SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.

Source page: https://510kreport.com/device/K051126
Methodology: https://510kreport.com/methodology