# K220466: ibiomedi Electronic Stethoscope ES-2020

- Pathway: 510(k) (Traditional)
- Applicant: Sound Land Corp.
- Decided: Nov 3, 2022 after 259 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: 6 generations back to K771653 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160023: Electronic Stethoscope DS301, Imediplus, Inc. (2016) Summary page 4.

## Indications for use
The ibiomedi Electronic Stethoscope ES-2020 is used to detect sound from the heart, arteries, veins, breathing sounds from the anterior/posterior/lateral chest and throat sounds in the neck. The chest piece is designed for children who are over two years old, teenagers and adults. It can be applied to any body type and can only be used for the purpose of medical diagnosis in clinics or hospitals.

Source page: https://510kreport.com/device/K220466
Methodology: https://510kreport.com/methodology