# K160023: Electronic Stethoscope DS301

- Pathway: 510(k) (Traditional)
- Applicant: Imediplus, Inc.
- Decided: Sep 30, 2016 after 268 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: 5 generations back to K771653 (1977). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 6.

## Most influential descendants
- K173663: Electronic Stethoscope DS3011A (2018), 1 descendant of its own
- K220466: ibiomedi Electronic Stethoscope ES-2020 (2022), 0 descendants of its own
- K182196: Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (2018), 0 descendants of its own

## Indications for use
The IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from the heart, lung, 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/K160023
Methodology: https://510kreport.com/methodology