Cleared Traditional

K961937 - SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM

K961937 is an FDA 510(k) clearance for SIMULSCOPE AUSCULTATION AND SIMULSCOPE ..., manufactured by Delphi Consulting Group. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K961937 · Delphi Consulting Group · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
203d
Days
Class 2
Risk

K961937 is an FDA 510(k) clearance for the SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Delphi Consulting Group (Houston, US). The FDA issued a Cleared decision on December 9, 1996 after a review of 203 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 - K961937

510(k) Number K961937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date December 09, 1996
Days to Decision 203 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 125d · This submission: 203d
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 136
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K961937.
3M LITTMANN ELECTRONIC STETHOSCOPE
K961848 · Minnesota Mining and Mfg. Co. · Sep 1997
TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE
K963418 · Transmedica, Inc. · May 1997
CARETONE II
K963678 · American Telecare, Inc. · Feb 1997
STETHOS
K963621 · Theratechnologies, Inc. · Dec 1996
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · Graham-Field, Inc. · Jul 1996
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · Delphi Consulting Group · Jun 1996
K961937 · SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM
Download PDF FDA Summary Delphi Consulting Gro…