# K213794: Eko Murmur Analysis Software (EMAS)

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: Jun 29, 2022 after 205 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). 99 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 103 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.
- K192004: Eko Analysis Software, Eko Devices, Inc. (2020) Summary page 4.

## Most influential descendants
- K240901: Stethophone (2024), 1 descendant of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own
- K251494: Eko Foundation Analysis Software with Transformers (EFAST) (2025), 0 descendants of its own

## Indications for use
The Eko Murmur Analysis Software (EMAS) is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur. The Eko Murmur Analysis Software is not intended 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. The Eko Murmur Analysis Software is intended for use on pediatric and adult patients.

Source page: https://510kreport.com/device/K213794
Methodology: https://510kreport.com/methodology