# K252284: eMurmur Heart AI

- Pathway: 510(k) (Traditional)
- Applicant: Csd Labs
- Decided: Dec 19, 2025 after 150 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). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220766: eMurmur Heart AI, Csd Labs GmbH (2022) Summary page 5.

## Indications for use
The eMurmur Heart AI software is a decision support system for the automated evaluation of recorded patient heart sounds. It identifies the first (S1) and second (S2) heart sounds, the presence of abnormal heart murmurs, and the absence of abnormal heart murmurs, with the latter including cases of no murmurs and innocent murmurs. eMurmur Heart AI also determines the average loudness of individual heart sound components, including S1, systole, S2, and diastole, as well as their respective loudness ratios. eMurmur Heart AI is indicated for use in settings where auscultation can be performed properly by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data. eMurmur Heart AI is intended for use on pediatric and adult patients.

Source page: https://510kreport.com/device/K252284
Methodology: https://510kreport.com/methodology