Cleared Traditional

K002047 - DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

K002047 is an FDA 510(k) clearance for DRG PURETONE STETHOSCOPE WITH DRG ANTIM..., manufactured by Doctor'S Research Group, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K002047 · Doctor'S Research Group, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
139d
Days
Class 2
Risk

K002047 is an FDA 510(k) clearance for the DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL.... Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 139 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.

FDA 510(k) Submission Details - K002047

510(k) Number K002047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date November 22, 2000
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 155
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K002047.
3M LITTMANN
K003723 · 3M Company · Mar 2001
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE
K003485 · Cybercare Technologies, Inc. · Jan 2001
EHC400 DESKTOP PATIENT STATION
K002984 · Cybercare Technologies, Inc. · Dec 2000
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
K001788 · Erecords Enterprises · Nov 2000
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
K001306 · Andromed, Inc. · Jul 2000
GEMINI E
K993623 · Allen Medical Instruments Corp. · Jun 2000
K002047 · DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
Download PDF FDA Summary Doctor'S Research Gro…