Cleared Traditional

K162589 - Adscope 658 Electronic Stethoscope

K162589 is the FDA 510(k) clearance for Adscope 658 Electronic Stethoscope by American Diagnostic Corp.. It is a Class 2 Cardiovascular device (product code DQD) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K162589 · American Diagnostic Corp. · Cardiovascular device
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Mar 2017
Decision
175d
Days
Class 2
Risk

K162589 is an FDA 510(k) clearance for the Adscope 658 Electronic Stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on March 10, 2017 after a review of 175 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K162589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2016
Decision Date March 10, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 K162589.
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K083903 · 3M Company · Jul 2009
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K051790 · 3M Company · Jul 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005