Cleared Traditional

K162589 - Adscope 658 Electronic Stethoscope

K162589 is an FDA 510(k) clearance for Adscope 658 Electronic Stethoscope, manufactured by American Diagnostic Corp.. The device is a Class 2 Cardiovascular device with 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.

FDA 510(k) Submission Details - K162589

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
Combination Product No
PCCP Authorized No
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.

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 K162589.
Stethee Pro
K172296 · M3Dicine Pty , Ltd. · Oct 2017
CADence System
K170928 · Aum Cardiovascular, Inc. · Aug 2017
Eko Model E5 System (EME5), Eko DUO
K170874 · Eko Devices, Inc. · May 2017
Tyto Stethoscope
K160401 · Tyto Care , Ltd. · Oct 2016
Electronic Stethoscope DS301
K160023 · Imediplus, Inc. · Sep 2016
Steth IO
K160016 · Stratoscientific, Inc. · Jul 2016
K162589 · Adscope 658 Electronic Stethoscope
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