# K181882: eKuore One electronic interface for stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Chip Ideas Electronics S.L.
- Decided: Mar 27, 2019 after 257 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: 1 generation back to K151319 (2015). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K201742: eKuore One Wireless Electronic Interface for stethoscope (2020), 0 descendants of its own

## Indications for use
The eKuore One 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 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/K181882
Methodology: https://510kreport.com/methodology