Skip to content

Sensicardiac

by Diacoustic Medical (Pty) 510(k)

Active United States

510(k) K121617

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121617 Date27 Jul 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sensiciardiac is an electronic auscultatory device intended to provide support to the physician in the evaluation of patients' heart sounds. It acquires and records the acoustic signals of the heart and analyzes these signals.

It is supplied as a reusable device for use in clinical settings. The device has received FDA 510(k) clearance under product code DQD and is classified as a Class II electronic stethoscope for cardiovascular applications.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sensiciardiac device used for?

    The Sensiciardiac is an electronic auscultatory device intended to support physicians in evaluating patients' heart sounds by acquiring, recording, and analyzing acoustic signals from the heart.

  • Is the Sensiciardiac device reusable or single-use?

    The Sensiciardiac is supplied as a reusable device for use in clinical settings, meaning it can be cleaned and used multiple times following appropriate infection control procedures.

  • What regulatory pathway was used for the Sensiciardiac device?

    The Sensiciardiac received FDA 510(k) clearance under product code DQD, indicating it was found substantially equivalent to a legally marketed predicate device.

  • What classification does the Sensiciardiac device have?

    The Sensiciardiac is classified as a Class II electronic stethoscope for cardiovascular applications, based on its FDA 510(k) clearance and product code DQD.