Cleared Traditional

K170928 - CADence System

K170928 is an FDA 510(k) clearance for CADence System, manufactured by Aum Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K170928 · Aum Cardiovascular, Inc. · Cardiovascular device
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Aug 2017
Decision
127d
Days
Class 2
Risk

K170928 is an FDA 510(k) clearance for the CADence System. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Aum Cardiovascular, Inc. (Northfield, US). The FDA issued a Cleared decision on August 3, 2017 after a review of 127 days - within the typical 510(k) review window.

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 Aum Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K170928

510(k) Number K170928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date August 03, 2017
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 61
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K170928.
Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
K182196 · Imediplus, Inc. · Sep 2018
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CliniCloud Stethoscope
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Adscope 658 Electronic Stethoscope
K162589 · American Diagnostic Corp. · Mar 2017
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
K060321 · American Diagnostic Corp. · May 2006