Cleared Traditional

K121144 - ELECTRONIC STETHOSCOPE

K121144 is an FDA 510(k) clearance for ELECTRONIC STETHOSCOPE, manufactured by Sharp Corporation. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K121144 · Sharp Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K121144

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
Combination Product No
PCCP Authorized No
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.

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 127
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K121144.
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