# K181988: eMurmur ID

- Pathway: 510(k) (Traditional)
- Applicant: Csd Labs GmbH
- Decided: Apr 17, 2019 after 266 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: 11 generations back to K910772 (1991). 53 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application, Diacoustic Medical Devices (Pty), Ltd. (2013) Summary page 4.

## Most influential descendants
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own
- K220766: eMurmur Heart AI (2022), 1 descendant of its own
- K252284: eMurmur Heart AI (2025), 0 descendants of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own

## Indications for use
The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur. eMurmur ID 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 ID 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/K181988
Methodology: https://510kreport.com/methodology