# K110704: SENSI

- Pathway: 510(k) (Traditional)
- Applicant: Diacoustic Medical Devices (Pty), Ltd.
- Decided: Jun 24, 2011 after 102 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: 8 generations back to K910772 (1991). 49 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 63 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.
- K013725: Meditron II Thesterthoscope System, Meditron AS (2002) Summary page 1.

## Most influential descendants
- K121617: Sensicardiac (2012), 10 descendants of its own
- 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

## Indications for use
The Sensi device consisting of the Sensi Diagnostic Heart Murmur Software, the WelchAllyn Master Elite Stethoscope and WelchAllyn USB Analyzer is a decision support device intended to be used on a single patient to assist the medical examiner in analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to distinguish between normal/physiological and pathological heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and analyze these signals. The acoustic heart signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs. Sensi indicates whether or not a recorded heart sound contains a suspected heart murmur and the confidence with which the analysis was made The device must be used in a clinical setting by trained personnel with the prescribed accessories and all relevant patient information must be taken into consideration before a diagnosis is made. The interpretations of heart sounds offered by the Sensi device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. Sensi is not intended to be a diagnostic device. It does not supersede the judgment of the qualified medical personnel. The device is intended to aid the physician in the evaluation of heart sounds. The physicians responsible for reviewing and interpreting the results, along with the auscultatory findings and medical history, in making a referral decision.

Source page: https://510kreport.com/device/K110704
Methodology: https://510kreport.com/methodology