# K192004: Eko Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Eko Devices, Inc.
- Decided: Jan 15, 2020 after 173 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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). 97 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170798: Dictum Health, Dictum Health, Inc. (2017) Summary page 4.
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application, Diacoustic Medical Devices (Pty), Ltd. (2013) Summary page 4.
- K073545: Audicor, Hemo Ambulatory Monitor, Inovise Medical, Inc. (2008) Summary page 4.
- K180234: physiQ Heart Rhythm Module, Physiq, Inc. (2018) 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
- 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 Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).

Source page: https://510kreport.com/device/K192004
Methodology: https://510kreport.com/methodology