# K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application

- Pathway: 510(k) (Traditional)
- Applicant: Diacoustic Medical Devices (Pty), Ltd.
- Decided: Sep 4, 2013 after 142 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: 10 generations back to K910772 (1991). 52 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121617: Sensicardiac, Diacoustic Medical (Pty) (2012) Summary page 1.

## Most influential descendants
- K181988: eMurmur ID (2019), 7 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- 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

## Indications for use
The SensiCardiac Mobi is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds. The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the SensiCardiac Mobi are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.

Source page: https://510kreport.com/device/K131044
Methodology: https://510kreport.com/methodology