Cleared Traditional

K031517 - ZARGIS ACOUSTIC CARDIOSCAN

K031517 is an FDA 510(k) clearance for ZARGIS ACOUSTIC CARDIOSCAN, manufactured by Zargis Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K031517 · Zargis Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
377d
Days
Class 2
Risk

K031517 is an FDA 510(k) clearance for the ZARGIS ACOUSTIC CARDIOSCAN. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Zargis Medical Corp. (Princeton, US). The FDA issued a Cleared decision on May 26, 2004 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Zargis Medical Corp. devices

FDA 510(k) Submission Details - K031517

510(k) Number K031517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2003
Decision Date May 26, 2004
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
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 63
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K031517.
HL 200 ELECTRONIC STETHOSCOPE
K050169 · Health & Life Co., Ltd. · Apr 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
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001
3M LITTMANN
K003723 · 3M Company · Mar 2001
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992