# K220099: eClinic Stethopod

- Pathway: 510(k) (Traditional)
- Applicant: Homediagnostic, LLC
- Decided: Oct 20, 2022 after 281 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 4.

## Indications for use
eClimic Stethopod 1s an Electronic Stethoscope. It converts patient auscultation sound (heart, ngs, bowel, arteries, and veins) into audio signal and transmits it to clinicians by clmically defined virtual appointment methods. It 1s intended to be used by professional users in a clinical environment or by lay users in a nonclinical or climical environment fo assist remote healthcare professionals’ physical assessment. The device is not intended for self-diagnosis. eClmic Stethopod 1s intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.

Source page: https://510kreport.com/device/K220099
Methodology: https://510kreport.com/methodology