# K200776: Eko CORE

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: Apr 6, 2020 after 12 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: 8 generations back to K952882 (1996). 23 ancestors in all.
13 later devices descend from it; 8 cite it directly.
0 of 37 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.
- K181612: Tyto Stethoscope (OTC), Tyto Care, Ltd. (2018) Summary page 4.

## Most influential descendants
- 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
- K220470: Smart Wireless Stethoscope (2022), 1 descendant of its own

## Indications for use
The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Source page: https://510kreport.com/device/K200776
Methodology: https://510kreport.com/methodology