Cleared Traditional

K121617 - SENSICARDIAC

K121617 is an FDA 510(k) clearance for SENSICARDIAC, manufactured by Diacoustic Medical (Pty). The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K121617 · Diacoustic Medical (Pty) · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
56d
Days
Class 2
Risk

K121617 is an FDA 510(k) clearance for the SENSICARDIAC. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Diacoustic Medical (Pty) (Crofton, US). The FDA issued a Cleared decision on July 27, 2012 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K121617

510(k) Number K121617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date July 27, 2012
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQD Stethoscope, Electronic

All 132
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K121617.
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
K131044 · Diacoustic Medical Devices (Pty) , Ltd. · Sep 2013
CARDIOSLEEVE
K131287 · Rijuven Corp · Jun 2013
ELECTRONIC STETHOSCOPE
K121144 · Sharp Corporation · Sep 2012
SENSI
K110704 · Diacoustic Medical Devices (Pty) , Ltd. · Jun 2011
A SCOPE
K103499 · Active Signal Technologies, Inc. · Mar 2011
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
K103516 · Inovise Medical, Inc. · Feb 2011
K121617 · SENSICARDIAC
Download PDF FDA Summary Diacoustic Medical (P…