# K231551: Stethophone

- Pathway: 510(k) (Traditional)
- Applicant: Sparrow Acoustics, Inc.
- Decided: Oct 12, 2023 after 135 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). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222871: Stethophone v1, Sparrow Acoustics, Inc. (2023) Summary page 5.
- K200776: Eko CORE, Eko Devices, Inc. (2020) Summary page 5.

## Most influential descendants
- K240901: Stethophone (2024), 1 descendant of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own

## Indications for use
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.

Source page: https://510kreport.com/device/K231551
Methodology: https://510kreport.com/methodology