# K121617: Sensicardiac

- Pathway: 510(k) (Traditional)
- Applicant: Diacoustic Medical (Pty)
- Decided: Jul 27, 2012 after 56 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: 9 generations back to K910772 (1991). 51 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K083309: Zargis Acoustic Cardioscan, Version 9.33, Zargis Medical Corp. (2009) Summary page 1.
- K052283: Heart STG System and Software, Stethographics, Inc. (2005) Summary page 1.
- K110704: SENSI, Diacoustic Medical Devices (Pty), Ltd. (2011) Summary page 1.

## Most influential descendants
- K131044: Sensicardiac Mobi Diagnostic Heart Murmur Application (2013), 9 descendants of its own
- 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

## Indications for use
The SensiCardiac 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 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/K121617
Methodology: https://510kreport.com/methodology