# K170874: Eko Model E5 System (EME5), Eko DUO

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: May 19, 2017 after 56 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K230111: CORE 500 Digital Stethoscope (2023), 1 descendant of its own
- K193518: Kosmos (2020), 1 descendant of its own
- K233609: CORE 500 Digital Stethoscope (2024), 0 descendants of its own
- K212100: Kosmos (2021), 0 descendants of its own
- K182040: Coala Heart Monitor (2019), 0 descendants of its own

## Indications for use
The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). 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. The device can be used on adults and pediatrics. The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device should not be used on infants weighing less than 10kg.

Source page: https://510kreport.com/device/K170874
Methodology: https://510kreport.com/methodology