# K201742: eKuore One Wireless Electronic Interface for stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Chip Ideas Electronics S.L.
- Decided: Nov 24, 2020 after 152 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- 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 K151319 (2015). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151319: Eko Electronic Stethoscope System, Eko Devices, Inc. (2015) Summary page 4.
- K181882: eKuore One electronic interface for stethoscope, Chip Ideas Electronics S.L. (2019) Summary page 6.

## Indications for use
The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Source page: https://510kreport.com/device/K201742
Methodology: https://510kreport.com/methodology