Cleared Traditional

JABES ELECTRONIC STETHOSCOPE (K031446) - FDA 510(k) Clearance

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

K031446 · Gs Technology Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
177d
Days
Class 2
Risk

K031446 is an FDA 510(k) clearance for the JABES ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Gs Technology Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 177 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 Gs Technology Co., Ltd. devices

Submission Details

510(k) Number K031446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date October 31, 2003
Days to Decision 177 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
52d slower than avg
Panel avg: 125d · This submission: 177d
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 52
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K031446.
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004
3M LITTMANN
K003723 · 3M Company · Mar 2001
ELECTRONIC STETHOSCOPE
K771653 · 3M Company · Sep 1977