# K252595: Stethophone Pro

- Pathway: 510(k) (Special)
- Applicant: Sparrow Acoustics, Inc.
- Decided: Sep 12, 2025 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: 14 generations back to K910772 (1991). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240901: Stethophone, Sparrow Acoustics, Inc. (2024) Summary page 6.

## Indications for use
Stethophone Pro 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 Pro is intended for use on adult patients. Stethophone Pro is not intended for self-diagnosis and not intended to be used as a sole means of diagnosis. Stethophone Pro can be used in clinical and nonclinical environments. For Rx-only: 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. The interpretations of heart sounds offered by the software are not diagnoses and are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. For OTC: When used without access to the automatic analysis results or under supervision of healthcare professional, Stethophone Pro is also intended to be used by lay users.

Source page: https://510kreport.com/device/K252595
Methodology: https://510kreport.com/methodology