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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

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 62
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K162589.
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
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005