# K240901: Stethophone

- Pathway: 510(k) (Traditional)
- Applicant: Sparrow Acoustics, Inc.
- Decided: Sep 19, 2024 after 170 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: 13 generations back to K910772 (1991). 121 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231551: Stethophone, Sparrow Acoustics, Inc. (2023) Summary page 6.
- K213794: Eko Murmur Analysis Software (EMAS), Eko Devices, Inc. (2022) Summary page 6.

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

## Indications for use
Stethophone Pro is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs). Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur. Stethophone Pro is not intended to be used as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. Stethophone Pro is intended for use on adult patients.

Source page: https://510kreport.com/device/K240901
Methodology: https://510kreport.com/methodology