# K233609: CORE 500 Digital Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Eko Health, Inc.
- Decided: Mar 28, 2024 after 136 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: 2 generations back to K170874 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230111: CORE 500 Digital Stethoscope, Eko Devices, Inc. (2023) Summary page 5.

## Indications for use
The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users 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 or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Source page: https://510kreport.com/device/K233609
Methodology: https://510kreport.com/methodology