# K230111: CORE 500 Digital Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: May 26, 2023 after 129 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 K170874 (2017). 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)
- K170874: Eko Model E5 System (EME5), Eko DUO, Eko Devices, Inc. (2017) Summary page 4.

## Most influential descendants
- K233609: CORE 500 Digital Stethoscope (2024), 0 descendants of its own

## Indications for use
The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Source page: https://510kreport.com/device/K230111
Methodology: https://510kreport.com/methodology