# K182196: Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

- Pathway: 510(k) (Traditional)
- Applicant: Imediplus, Inc.
- Decided: Sep 11, 2018 after 28 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: 7 generations back to K771653 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173663: Electronic Stethoscope DS3011A, Imediplus, Inc. (2018). Cleared while this submission was under review Summary page 4.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 4.

## Indications for use
The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.

Source page: https://510kreport.com/device/K182196
Methodology: https://510kreport.com/methodology