Cardiovascular · 510(k) · 2012
SENSICARDIAC
DIACOUSTIC MEDICAL (PTY). Cleared by FDA on 27 July 2012 under submission K121617, product code DQD (stethoscope, electronic). What FDA's record says, in FDA's words.
Device record · K121617
- Device. SENSICARDIACDEVICE
- Company. DIACOUSTIC MEDICAL (PTY)COMPANY
- Decision. 27 July 2012, 510(k), substantially equivalent (traditional review); received 1 June 2012DECISION
- Panel. CardiovascularPANEL
- Product code. DQD, Stethoscope, ElectronicCODE
- Regulation. 21 CFR 870.1875, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, technological characteristics and safe ty and performance testing, iit is the conclusion of Diacoustic Medical that the Sensi device consisting of the Sensi Diagnostic Heart Murmur Software and a compatible electronic stethoscope is as safe and effective as the predicate devices and raises no new issues of safety and effectiveness. 22 StVLI DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 JUL 2 7 2012 Diacoustic Medical Devices C/O E.J.Smith 1468 Harwell Avenue Crofton, Maryland 21114 Re: K121617 Trade/ : SensiCardiac
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 7 reports filed against devices carrying product code DQD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00002
31 August 2026 · Malfunction · CORE 500 Digital Stethoscope · Eko Health, Inc. · report 3011651230-2026-00003
8 May 2026 · Malfunction · EKO ELECTRONIC STETHOSCIPE SYSTEM · EKO HEALTH, INC. · report 3011651230-2026-00001
CUSTOMER REPORTED WHILE CHARGING THEIR DEVICE THE DEVICE BECAME VERY HOT. THE DEVICE BECAME HOT TO THE POINT THE USER COULD NOT TOUCH THE DEVICE. FOLLOWING THE EVENT THE DEVICE WAS NO LONGER ABLE TO POWER ON. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2024 · Malfunction · CORE 500 DIGITAL STETHOSCOPE · EKO HEALTH, INC. · report 3011651230-2024-00001
CUSTOMER REPORTED THAT THE REFERENCED DEVICE OVERHEATED AND THE USB-C CHARGING CABLE MELTED DURING CHARGING. NO DEATH OR SERIOUS INJURY REPORTED.
12 November 2013 · Other · 3M LITTMANN ELECTRONIC STETHOSCOPE · 3M HEALTH CARE · report 2110898-2013-00071
IT WAS REPORTED THAT A FEMALE RESPIRATORY THERAPIST, WITH A SEVERE LATEX ALLERGY, REPORTED SHE USED A SOFT BLACK EAR TIP THAT SHE BORROWED FROM HER BOSS AFTER HER SOFT GREY EAR TIP SPLIT. REPORTEDLY, SHE CLEANED IT WITH ALCOHOL BEFORE USING IT ON HER SCOPE. THE USER USED IT IN A PATIENT'S ROOM AND HER EAR BECAME BEET RED, SWOLLEN, STARTED ITCHING AND THE REACTION SPREAD TO HER HEAD, FACE, AND ARM. REPORTEDLY WENT TO THE ER AND WAS TREATED WITH BENADRYL AND DECADRON (IM INJECTION) AND A […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQD, in Cardiovascular, or cleared in 2012. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.