# K220766: eMurmur Heart AI

- Pathway: 510(k) (Special)
- Applicant: Csd Labs GmbH
- Decided: May 31, 2022 after 76 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: 12 generations back to K910772 (1991). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181988: eMurmur ID, Csd Labs GmbH (2019) Summary page 4.

## Most influential descendants
- K252284: eMurmur Heart AI (2025), 0 descendants of its own

## Indications for use
The ’eMurmur Heart AI’ software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart AI identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed 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.

Source page: https://510kreport.com/device/K220766
Methodology: https://510kreport.com/methodology