# K261694: CORE 300 Digital Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Eko Health, Inc.
- Decided: Jul 23, 2026 after 62 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: 9 generations back to K952882 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200776: Eko CORE, Eko Devices, Inc. (2020) Summary page 5.

## Indications for use
The CORE 300 Digital Stethoscope is intended to electronically amplify, filter, and transmit body sounds, and to calculate heart rate. The device is intended for use by healthcare professionals or lay users on pediatric and adult patients. For lay users, the device output is not intended to be interpreted or used to take clinical action without consultation with a healthcare professional.

Source page: https://510kreport.com/device/K261694
Methodology: https://510kreport.com/methodology