Cleared Traditional

ELECTRONIC STETHOSCOPE (K121144) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121144 · Sharp Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
163d
Days
Class 2
Risk

K121144 is an FDA 510(k) clearance for the ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Sharp Corporation (Richardson, US). The FDA issued a Cleared decision on September 26, 2012 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sharp Corporation devices

Submission Details

510(k) Number K121144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date September 26, 2012
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K121144.
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
K182196 · Imediplus, Inc. · Sep 2018
Electronic Stethoscope DS3011A
K173663 · Imediplus, Inc. · Aug 2018
CliniCloud Stethoscope
K173448 · Stethocloud Pty.Ltd (Clinicloud) · Jan 2018
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005