# K151319: Eko Electronic Stethoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: Aug 28, 2015 after 102 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200776: Eko CORE (2020), 13 descendants of its own
- K231551: Stethophone (2023), 2 descendants of its own
- K210736: doctorgram Stethoscope DES-I (2021), 2 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own
- K212975: MedWand (2022), 1 descendant of its own

## Indications for use
The Eko Electronic Stethoscope System 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. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. It can 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/K151319
Methodology: https://510kreport.com/methodology