# K193631: Stethee Pro 1, Stethee Pro Software System

- Pathway: 510(k) (Traditional)
- Applicant: M3Dicine Pty, Ltd.
- Decided: Oct 9, 2020 after 287 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)
- K172296: Stethee Pro, M3Dicine Pty, Ltd. (2017) Summary page 5.

## Indications for use
The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.

Source page: https://510kreport.com/device/K193631
Methodology: https://510kreport.com/methodology